Drugs and Biologics
BACKGROUND
On November 21, 1997, President Clinton signed into law the
Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115) (Modernization Act). The Modernization Act (21 U.S.C. 355a(b)) required the Food and Drug Administration (FDA), after consultation with experts in pediatric research, to develop, prioritize, and publish an initial list of approved drugs for which additional pediatric information may produce health benefits in the pediatric population (the list). FDA published the initial prioritized list (priority list) on May 20, 1998. FDA is required to update the priority list annually. Attachments A and B represent the Agency’s third annual update of the priority list. The list is published below and at the Dockets Management Branch in Docket No. 98N-0056. A copy of the list is also available through fax-on-demand (1-800-342-2722, Document number 0504).For purposes of this list, "approved drug" is defined by FDA as a drug that is approved for use in adults for indications that occur in the pediatric population. This list is intended solely to satisfy the requirement of 21 U.S.C. 355a(b). The list does not constitute a written request under 21 U.S.C. 355a(c). Inclusion of a drug on the list does not necessarily mean that the drug is entitled to pediatric exclusivity. Inclusion of a drug on the list does not mean that a sponsor is required to take any action.
If an interested party wishes to have a drug added to the priority list, it should petition the Agency in accordance with the requirements of 21 CFR 10.30. Petitioners should include in the header of their petition, "PEDIATRIC PRIORITY LIST."
For further information see "Guidance for Industry: Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug and Cosmetic Act."
Attachment A
Pediatric Priority List of Drugs Regulated by the
Center for Drug Evaluation and Research
Product Name |
Indication |
CDER Division |
Acarbose |
Type 2 Diabetes. |
Metabolic And Endocrine Drug Products |
Acebutolol |
Hypertension. |
Cardio-Renal Drug Products |
Acetaminophen/ Aspirin/ Caffeine |
Treatment of pain associated with migraine headache. |
Over-The-Counter Drug Products |
Adenosine |
Conversion to sinus rhythm of paroxysmal supraventricular tachycardia, including that associated with accessory bypass tracts. |
Cardio-Renal Drug Products |
Albendazole |
Treatment of hydatid disease and neurocysticercosis. |
Special Pathogen And Immunologic Drug Products |
Albuterol (racemic and (R) enantiomer) |
Treatment and prevention of bronchospasm in patients with reversible obstructive airway disease. |
Pulmonary Drug Products |
Alfentanil |
Anesthesia maintenance, induction of anesthesia, monitored anesthesia care. |
Anesthetic, Critical Care And Addiction Drug Products |
Alprazolam |
Anxiety. |
Neuropharmacological Drug Products |
Amantadine |
Prophylaxis and treatment of illness caused by influenza virus. |
Anti-Viral Drug Products |
Amifostine |
Chemoprotective agent that selectively protects against the serious toxicities associated with intensive regimens of platinum and alkylating agent chemotherapy. |
Oncology Drug Products |
Amiloride |
Hypertension. |
Cardio-Renal Drug Products |
Aminocaproic Acid |
Enhancing hemostasis when fibrinolysis contributes to bleeding. |
Gastrointestinal And Coagulation Drug Products |
Amiodarone |
Treatment and prophylaxis of frequently recurring ventricular fibrillation and hemodynamically destabilizing ventricular tachycardia. |
Cardio-Renal Drug Products |
Amlexanox |
Treatment of oral aphthous ulcers. |
Dermatologic And Dental Drug Products |
Amlodipine |
Hypertension. |
Cardio-Renal Drug Products |
Amphetamine/ Dextroamphetamine |
ADHD. |
Neuropharmacological Drug Products |
Amphotericin B |
Treat potentially life-threatening fungal infections. |
Special Pathogen And Immunologic Drug Products |
Ampicillin |
Respiratory tract infections, bacterial meningitis, septicemia, endocarditis, UTI, and gastrointestinal infections. |
Anti-Infective Drug Products |
Ampicillin/sulbactam |
Skin/skin structure infections and intraabdominal infections. |
Anti-Infective Drug Products |
Apraclonidine |
Adjunctive therapy in glaucoma patients. Control of acute IOP elevation after anterior-segment laser surgery. |
Anti-Inflammatory, Analgesic, And Ophthalmologic Drug Products |
Argatroban |
Anticoagulation in patients with heparin-induced thrombocytopenia. |
Gastrointestinal And Coagulation Drug Products |
Atorvastatin |
Heterozygous familial hypercholesterolemia. |
Metabolic And Endocrine Drug Products |
Atovaquone |
Treatment and prophylaxis of PCP infection in patients with HIV. |
Special Pathogen And Immunologic Drug Products |
Atracurium |
Neuromuscular blocking agent. |
Anesthetic, Critical Care And Addiction Drug Products |
Atropine |
Reversal agent or antagonist of nondepolarizing muscle relaxants. |
Anesthetic, Critical Care And Addiction Drug Products |
Azathioprine |
Juvenile rheumatoid arthritis. |
Anti-Inflammatory, Analgesic, And Ophthalmologic Drug Products |
Azelastine |
Allergic rhinitis. |
Pulmonary Drug Products |
Azithromycin |
Prevention of MAI infection. |
Special Pathogen And Immunologic Drug Products |
Azithromycin |
Pneumonia (community acquired). |
Anti-Infective Drug Products |
Aztreonam |
UTI, lower respiratory tract infections, septicemia, skin infections, intra-abdominal infections. |
Anti-Infective Drug Products |
Baclofen |
Treatment of spasticity resulting from spinal cord injury or multiple sclerosis in patients whose oral baclofen therapy has failed. |
Neuropharmacological Drug Products |
Balsalazide |
Treatment of mild to moderate ulcerative colitis. |
Gastrointestinal And Coagulation Drug Products |
Beclomethasone |
For patients who require chronic treatment with corticosteroids for control of the symptoms of bronchial asthma. Relief of symptoms of allergic and non-allergic (vasomotor) rhinitis. |
Pulmonary Drug Products |
Benazepril |
Hypertension. |
Cardio-Renal Drug Products |
Bendroflumethiazide |
Hypertension. |
Cardio-Renal Drug Products |
Betamethasone |
Corticosteroid responsive dermatoses. |
Dermatologic And Dental Drug Products |
Betaxolol |
Hypertension. |
Cardio-Renal Drug Products |
Betaxolol |
Control of IOP for glaucoma and ocular hypertensive patients. |
Anti-Inflammatory, Analgesic, And Ophthalmologic Drug Products |
Betaxolol/ Pilocarpine |
Lowering of intraocular pressure in patients with primary open angle glaucoma or ocular hypertension. |
Anti-Inflammatory, Analgesic, And Ophthalmologic Drug Products |
Bitolterol |
Prophylaxis and treatment of asthma or bronchospasm. |
Pulmonary Drug Products |
Brimonidine |
Lowering intraocular pressure in patients with chronic open angle glaucoma or ocular hypertension. |
Anti-Inflammatory, Analgesic, And Ophthalmologic Drug Products |
Brinzolamide |
Lower intraocular pressure. |
Anti-Inflammatory, Analgesic, And Ophthalmologic Drug Products |
Brompheniramine/ Pseudoephedrine |
Cold and allergy relief. |
Over-The-Counter Drug Products |
Budesonide |
Prevention and relief of symptoms of seasonal or perennial allergic and nonallergic (vasomotor) rhinitis. Treatment of bronchial asthma. |
Pulmonary Drug Products |
Bumetanide |
Treatment of edema (CHF, liver or kidney disease). |
Cardio-Renal Drug Products |
Bupivacaine |
Caudal/epidural anesthesia single administration or continuous infusions. Local anesthetic infiltration. Spinal/subarachnoid anesthesia. Intra-articular route. Regional nerve block. Subarachnoid use in neonates. |
Anesthetic, Critical Care And Addiction Drug Products |
Bupropion |
Aid to smoking cessation treatment. |
Anesthetic, Critical Care And Addiction Drug Products |
Bupropion |
Treatment of depression. |
Neuropharmacological Drug Products |
Buspirone |
Anxiety. |
Neuropharmacological Drug Products |
Busulfan |
Chronic myelogenous leukemia. |
Oncology Drug Products |
Calcipotriene |
Treatment of plaque psoriasis. |
Dermatologic And Dental Drug Products |
Calcitriol |
Management of hypocalcemia in patients undergoing chronic renal dialysis, end stage renal disease. |
Metabolic And Endocrine Drug Products |
Calcium acetate |
For treatment of hyperphosphatemia in end stage renal failure patients. |
Metabolic And Endocrine Drug Products |
Candesartan |
Hypertension. |
Cardio-Renal Drug Products |
Captopril |
Treatment of heart failure. Hypertension. |
Cardio-Renal Drug Products |
Carmustine |
Central nervous system malignancies, lymphoma. |
Oncology Drug Products |
Carteolol |
Hypertension. |
Cardio-Renal Drug Products |
Carteolol |
Treatment of chronic open-angle glaucoma or ocular hypertension. |
Anti-Inflammatory, Analgesic, And Ophthalmologic Drug Products |
Carvedilol |
Treatment of heart failure. |
Cardio-Renal Drug Products |
Caspofungin |
Treatment of invasive aspergillosis in patients refractory to or intolerant of other therapies. |
Special Pathogen And Immunologic Drug Products |
Cefdinir |
Uncompliated skin and skin structure infections. Community-acquired pneumonia. Acute bacterial otitis media. |
Anti-Infective Drug Products |
Cefepime |
Intra-abdominal infections. UTI, skin infections, pneumonia. |
Anti-Infective Drug Products |
Cefixime |
Uncomplicated gonorrhea. |
Anti-Infective Drug Products |
Cefprozil |
Otitis media. Uncomplicated skin and skin structure infections. |
Anti-Infective Drug Products |
Ceftizoxime |
Lower respiratory tract infections, urinary tract infections, intra-abdominal infections, skin and skin structure infections, and bone and joint infections. |
Anti-Infective Drug Products |
Celecoxib |
Rheumatoid arthritis. |
Anti-Inflammatory, Analgesic, And Ophthalmologic Drug Products |
Cephalexin |
Bone and joint infections. Skin and skin structure infections. |
Anti-Infective Drug Products |
Cerivastatin |
Heterozygous familial hypercholesterolemia. |
Metabolic And Endocrine Drug Products |
Cetirizine |
Seasonal allergic rhinitis; perennial allergic rhinitis; and chronic idiopathic urticaria. |
Pulmonary Drug Products |
Chloroquine |
Suppressive treatment and acute attacks of malaria due to P. vivax, P. malariae, P. ovale, and susceptible strains of P. falciparum. Treatment of extra-intestinal amebiasis. |
Special Pathogen And Immunologic Drug Products |
Chlorothiazide |
Hypertension. |
Cardio-Renal Drug Products |
Chlorpheniramine |
Allergy and cold relief. |
Over-The-Counter Drug Products |
Chlorthalidone |
Hypertension. |
Cardio-Renal Drug Products |
Cholestyramine |
For relief of pruritus associated with partial biliary obstruction. |
Gastrointestinal And Coagulation Drug Products |
Cimetidine |
Prevention of upper GI bleeding in critically ill patients. Treatment of symptomatic GERD. Treatment of erosive esophagitis. Treatment of ulcer disease. |
Gastrointestinal And Coagulation Drug Products |
Ciprofloxacin |
Corneal ulcers and conjunctivitis. |
Anti-Inflammatory, Analgesic, And Ophthalmologic Drug Products |
Ciprofloxacin |
Complicated intra-abdominal infections. Typhoid fever. Febrile neutropenia. Nosocomial pneumonia. Bone and joint infections. Infectious diarrhea. |
Special Pathogen And Immunologic Drug Products |
Cisatracurium |
Intermediate duration neuromuscular blocking agent for use in the operating room and intensive care unit. |
Anesthetic, Critical Care And Addiction Drug Products |
Citalopram |
Treatment of Depression. |
Neuropharmacological Drug Products |
Clarithromycin |
Treatment of MAI infection. |
Special Pathogen And Immunologic Drug Products |
Clemastine |
Allergic rhinitis and urticaria. Common cold. |
Pulmonary Drug Products |
Clemastine/ Phenylpropanolamine |
Cold and allergy relief; relief of nasal congestion associated with sinusitis. |
Over-The-Counter Drug Products |
Clobetasol |
Topical treatment of inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses. |
Dermatologic And Dental Drug Products |
Clomipramine |
Obsessive compulsive disorders. |
Neuropharmacological Drug Products |
Clonazepam |
Lennox-Gastaut syndrome, akinetic & myoclonic seizures; Pananti convulsion; treatment of (convulsions) akinetic myoclonic and absence seizure. |
Neuropharmacological Drug Products |
Clonidine |
For continuous epidural administration as adjunctive therapy with intraspinal opiates for the treatment of pain in cancer patients. |
Anesthetic, Critical Care And Addiction Drug Products |
Clonidine |
Hypertension. |
Cardio-Renal Drug Products |
Clopidogril |
Prevent thrombotic events. |
Cardio-Renal Drug Products |
Clotrimazole/ Betamethasone |
Treatment of tinea pedis, tinea cruris, and tinea corporis. |
Dermatologic And Dental Drug Products |
Clozapine |
Psychotic disorders. |
Neuropharmacological Drug Products |
Corticorelin Ovine |
Diagnostic aid for adrenal cortical function and Cushings syndrome. |
Metabolic And Endocrine Drug Products |
Cromolyn |
Prophylaxis/treatment of asthma. |
Pulmonary Drug Products |
Cyclosporine |
Juvenile rheumatoid arthritis. |
Anti-Inflammatory, Analgesic, And Ophthalmologic Drug Products |
D-penicillamine |
Juvenile rheumatoid arthritis. |
Anti-Inflammatory, Analgesic, And Ophthalmologic Drug Products |
Dacarbazine |
Hodgkin's Disease. |
Oncology Drug Products |
Dapiprazole |
Use in the practice of ophthalmology to reverse mydriasis. |
Anti-Inflammatory, Analgesic, And Ophthalmologic Drug Products |
Deferoxamine |
Treatment of acute iron intoxication. |
Gastrointestinal And Coagulation Drug Products |
Delavirdine |
Treatment of HIV infection. |
Anti-Viral Drug Products |
Desmopressin |
Central diabetes insipidus. Treatment of hemophilia A and mild to moderate von Willebrand disease. |
Metabolic And Endocrine Drug Products |
Dexmedetomidine |
Sedation of initially intubated and mechanically ventilated patients in an ICU setting. |
Anesthetic, Critical Care And Addiction Drug Products |
Dexrazoxane |
For the prevention of cardiomyopathy associated with doxorubicin administration. |
Oncology Drug Products |
Dezocine |
Pain management when use of opioid analgesic indicated. |
Anesthetic, Critical Care And Addiction Drug Products |
Diazepam |
Management of selected, refractory patients with epilepsy, on stable regimes of AEDs, who require intermittent use of diazepam to control bouts of increased seizure activity. Anxiety disorders. |
Neuropharmacological Drug Products |
Diazoxide |
Use in hypertensive emergencies. |
Cardio-Renal Drug Products |
Diclofenac |
Treatment of postoperative inflammation following cataract extraction. Juvenile rheumatoid arthritis. |
Anti-Inflammatory, Analgesic, And Ophthalmologic Drug Products |
Diclofenac/Misoprostol |
Treatment of rheumatoid arthritis in patients at high risk of developing NSAID-induced ulcers and their complications. |
Gastrointestinal And Coagulation Drug Products |
Didanosine |
Treatment of HIV infection. |
Anti-Viral Drug Products |
Digoxin |
CHF in specific cardiovascular disorders and malformations. For rapid control of ventricular rate in the face of supraventricular tachycardia. |
Cardio-Renal Drug Products |
Dihydroergotamine |
Symptomatic treatment of common or classic migraine headaches. |
Neuropharmacological Drug Products |
Diltiazem |
Hypertension. |
Cardio-Renal Drug Products |
Dimercaprol |
Treatment of arsenic, gold, and mercury poisoning. |
Gastrointestinal And Coagulation Drug Products |
Disopyramide |
Arrhythmias. |
Cardio-Renal Drug Products |
Divalproex |
Therapy in simple (petit mal) & complex absence seizures & multiple seizure types. Monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures that occur either in isolation or in association with other types of seizures. Migraine prevention. Mania. |
Neuropharmacological Drug Products |
Dobutamine |
Treatment of heart failure. |
Cardio-Renal Drug Products |
Dofetilide |
Delay in recurrence of atrial fibrillation or flutter. |
Cardio-Renal Drug Products |
Dolasetron |
Prevention of chemotherapy-induced emesis. Treatment of post-operative nausea and vomiting. Prevention of post-operative nausea and vomiting. |
Gastrointestinal And Coagulation Drug Products |
Dopamine |
Treatment of heart failure. |
Cardio-Renal Drug Products |
Dorzolamide |
Lower intraocular pressure. |
Anti-Inflammatory, Analgesic, And Ophthalmologic Drug Products |
Dorzolamide/Timolol |
Lower intraocular pressue. |
Anti-Inflammatory, Analgesic, And Ophthalmologic Drug Products |
Doxacurium |
Indicated as an adjunct to general anesthesia, to provide skeletal muscle relaxation during surgery. |
Anesthetic, Critical Care And Addiction Drug Products |
Doxazosin |
Hypertension. |
Cardio-Renal Drug Products |
Doxepin |
Treatment of cutaneous histamine-mediated pruritus accompanying eczematous dermatitis. |
Dermatologic And Dental Drug Products |
Doxercalciferol |
Reduce IPTH levels in the management of secondary hyperparathyroidism in patients undergoing chronic renal dialysis. |
Metabolic And Endocrine Drug Products |
Droperidol |
Antiemetic. Adjunct for sedation prior to or during a procedure. Adjunct to general anesthesia. |
Anesthetic, Critical Care And Addiction Drug Products |
Edrophonium |
Reversal agent or antagonist of nondepolarizing neuromuscular blocking agents. |
Anesthetic, Critical Care And Addiction Drug Products |
Efavirenz |
Treatment of HIV infection. |
Anti-Viral Drug Products |
Enalaprilat |
Use in hypertensive emergencies. |
Cardio-Renal Drug Products |
Enoxacin |
Complicated urinary tract infections. |
Special Pathogen And Immunologic Drug Products |
Enoxaparin |
Treatment of deep venous thrombosis. |
Gastrointestinal And Coagulation Drug Products |
Epinephrine |
Intraosseous and endotracheal for resuscitation. |
Anesthetic, Critical Care And Addiction Drug Products |
Epoprostenol |
Pulmonary hypertension associated with scleroderma. Long term treatment of primary pulmonary hypertension. |
Gastrointestinal And Coagulation Drug Products |
Eprosartan |
Hypertension. |
Cardio-Renal Drug Products |
Esomeprazole |
Treatment of symptomatic GERD. Treatment of erosive esophagitis. |
Gastrointestinal And Coagulation Drug Products |
Ethacrynic acid |
Hypertension. |
Cardio-Renal Drug Products |
Ethambutol |
Pulmonary tuberculosis. |
Special Pathogen And Immunologic Drug Products |
Ethionamide |
Active tuberculosis (after failing primary drugs). |
Special Pathogen And Immunologic Drug Products |
Ethosuximide |
Control of absence epilepsy (petit mal). |
Neuropharmacological Drug Products |
Etomidate |
As an adjunct to endotracheal intubation. For induction of anesthesia. As a premedicant/sedative prior to or during a procedure. |
Anesthetic, Critical Care And Addiction Drug Products |
Famciclovir |
Herpes zoster and recurrent genital herpes. Treatment/suppression of recurrent genital herpes. Treatment of recurrent microcutaneous herpes simplex infection in HIV infected patients. |
Anti-Viral Drug Products |
Famotidine |
Treatment of symptomatic GERD. Treatment of erosive esophagitis. |
Gastrointestinal And Coagulation Drug Products |
Felbamate |
Monotherapy or adjunctive therapy for the treatment of partial seizures with and without generalization in patients with epilepsy. |
Neuropharmacological Drug Products |
Felodipine |
Hypertension. |
Cardio-Renal Drug Products |
Fenoldopam |
For emergency use in hypertensive emergencies. |
Cardio-Renal Drug Products |
Fentanyl |
Transdermal for pain control. For epidural administration by single shot or continuous infusion for postoperative or general pain management. For continuous intravenous infusion in the critical care setting. For general anesthesia. As a premedicant prior to or during a procedure. By continuous infusion/patient controlled analgesia. |
Anesthetic, Critical Care And Addiction Drug Products |
Ferric Ammonium Citrate |
Delineate the gastrointestinal tract in magnetic resonance imaging of the upper abdomen. |
Medical Imaging And Radiopharmaceutical Drug Products |
Ferrlecit |
Iron deficiency anemia in chronic hemodialysis patients on erythropoetin. |
Gastrointestinal And Coagulation Drug Products |
Ferumoxides |
Intended for the detection of lesions of the liver and spleen manifested by an alteration in RES distribution as an adjunct to MRI. |
Medical Imaging And Radiopharmaceutical Drug Products |
Ferumoxsil |
Used with magnetic resonance imaging to enhance delineation of the bowel in order to distinguish it from adjacent organs and areas of suspected pathology. |
Medical Imaging And Radiopharmaceutical Drug Products |
Fexofenadine |
Treatment of seasonal allergic rhinitis. |
Pulmonary Drug Products |
Fexofenadine/ Pseudoephedrine |
Treatment of seasonal allergic rhinitis. |
Pulmonary Drug Products |
Flecainide |
Treatment of life threatening ventricular arrhythmias. Prolonging the time to recurrence of supraventricular tachycardia. |
Cardio-Renal Drug Products |
Fluconazole |
Treatment of cryptococcal meningitis. Treatment of vaginal candidiasis. Prophylaxis against candidiasis in patients undergoing bone marrow transplantation, or who have received cytotoxic chemotherapy and/or radiation therapy. Treatment of oropharyngeal candidiasis. |
Special Pathogen And Immunologic Drug Products |
Flucytosine |
Serious infections caused by Candida (septicemia, endocarditis and urinary infections). |
Special Pathogen And Immunologic Drug Products |
Flumazenil |
Complete or partial reversal of benzodiazepine overdose, e.g., sedative effects or respiratory depression. |
Anesthetic, Critical Care And Addiction Drug Products |
Flunisolide |
Asthma. Management of symptoms of seasonal or perennial rhinitis. |
Pulmonary Drug Products |
Fluocinolone |
Relief of inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. |
Dermatologic And Dental Drug Products |
Fluoxetine |
Obsessive compulsive disorder. Treatment of depression. |
Neuropharmacological Drug Products |
Fluticasone |
Maintenance treatment of bronchial asthma. Relief of the symptoms of seasonal or perennial rhinitis. |
Pulmonary Drug Products |
Fluticasone |
Topical treatment of corticosteroid responsive dermatoses. |
Dermatologic And Dental Drug Products |
Fluvastatin |
Heterozygous familial hypercholesterolemia. |
Metabolic And Endocrine Drug Products |
Fomivirsen Sodium |
CMV retinitis. |
Anti-Inflammatory, Analgesic, And Ophthalmologic Drug Products |
Foscarnet |
Treatment of CMV retinitis in AIDS patients. |
Anti-Viral Drug Products |
Foscarnet |
CMV Retinitis. |
Anti-Inflammatory, Analgesic, And Ophthalmologic Drug Products |
Fosinopril |
Hypertension. |
Cardio-Renal Drug Products |
Fosphenytoin |
Short-term substitution for oral phenytoin. Prevention and treatment of seizures occurring during neurosurgery. Short-term parenteral administration when other means of phenytoin administration are unavailable, inappropriate, or deemed less advantageous. Control of generalized convulsive status epilepticus. |
Neuropharmacological Drug Products |
Furazolidine |
Specific and symptomatic treatment of bacterial or protozoal diarrhea and enteritis caused by susceptible organisms. |
Special Pathogen And Immunologic Drug Products |
Furosemide |
Treatment of edema (CHF, liver or kidney disease). Treatment of BPD and other forms of chronic lung disease. |
Cardio-Renal Drug Products |
Gadodiamide |
IV administration with magnetic resonance imaging in adult patients to provide contrast enhancement & facilitate visualization of central nervous system, as well as intrathoracic, intra-abdominal, pelvic and retroperitoneal regions of the body. |
Medical Imaging And Radiopharmaceutical Drug Products |
Gadopentetate |
Magnetic resonance imaging contrast medium for adult intracranial tumors(primary or metastatic). |
Medical Imaging And Radiopharmaceutical Drug Products |
Gadoversetamide |
Diagnostic drug for imaging the central nervous system and liver. |
Medical Imaging And Radiopharmaceutical Drug Products |
Gallium Citrate Ga-67 |
Useful to demonstrate the following malignancies: Hodgkins disease, lymphomas and bronchogenic carcinoma. |
Medical Imaging And Radiopharmaceutical Drug Products |
Ganciclovir |
CMV prophylaxis in adults (Oral). Life or sight threatening cytomegalovirus infection in immunocompromised patients (Intravenous). |
Anti-Viral Drug Products |
Ganciclovir Implant |
Treatment of cytomegalovirus retinitis. |
Anti-Inflammatory, Analgesic, And Ophthalmologic Drug Products |
Gemtuzumab |
Treatment of patients with CD-33 positive acute myeloid leukemia. |
Oncology Drug Products |
Glatiramer |
Slowing progression of disability and reducing frequency of relapses in patients with multiple sclerosis. |
Neuropharmacological Drug Products |
Gold |
Juvenile rheumatoid arthritis. |
Anti-Inflammatory, Analgesic, And Ophthalmologic Drug Products |
Granisetron |
Prevention of chemotherapy-induced emesis. |
Gastrointestinal And Coagulation Drug Products |
Guanabenz |
Hypertension. |
Cardio-Renal Drug Products |
Guanfacine |
Hypertension. |
Cardio-Renal Drug Products |
Halofantrine |
Treatment of mild to moderate acute malaria caused by Plasmodium falciparum or Plasmodium vivax. |
Special Pathogen And Immunologic Drug Products |
Heparin |
Prophylaxis and treatment of thromboembolic conditions (deep venous thrombosis, pulmonary embolism) and disseminated intravascular coagulation; for anticoagulation in blood transfusions, extracorporeal circulation, and dialysis procedures. |
Gastrointestinal And Coagulation Drug Products |
Human Albumin Microspheres, Octofluoropropane |
Opacify the left ventricle and improve the delineation of left ventricular endocardial borders. |
Medical Imaging And Radiopharmaceutical Drug Products |
Hydralazine |
Hypertension. |
Cardio-Renal Drug Products |
Hydrochlorothiazide |
Treatment of edema. Sparing calcium excretion. Hypertension. |
Cardio-Renal Drug Products |
Hydroflumethiazide |
Hypertension. |
Cardio-Renal Drug Products |
Hydromorphone |
For the control of persistent, exhausting cough or dry, nonproductive cough. Epidural administration for pain management. For the relief of moderate to severe pain. |
Anesthetic, Critical Care And Addiction Drug Products |
Hydroxychloroquine |
Juvenile rheumatoid arthritis. |
Anti-Inflammatory, Analgesic, And Ophthalmologic Drug Products |
Hydroxyurea |
Chronic myelocytic leukemia. |
Oncology Drug Products |
Ibuprofen/ Hydrocodone |
Analgesia. |
Anti-Inflammatory, Analgesic, And Ophthalmologic Drug Products |
Ibuprofen/ Pseudoephedrine |
Symptoms associated with sinusitis, common cold or flu including nasal congestion, headaches, body aches, pains, and fever. |
Over-The-Counter Drug Products |
Ibutilide |
Conversion of atrial fibrillation and flutter to normal sinus rhythm. |
Cardio-Renal Drug Products |
Imiglucerase |
Long-term enzyme replacement therapy for patients with Type 1 Gaucher disease resulting in one or more of the following: anemia, thrombocytopenia, bone disease or heptomegaly or splenomegaly. |
Metabolic And Endocrine Drug Products |
Imiquimod |
Topical treatment of external anogenital condyloma accuminata. |
Dermatologic And Dental Drug Products |
Indapamide |
Treatment of edema (CHF, liver or kidney disease). |
Cardio-Renal Drug Products |
Indinavir |
Treatment of HIV infection. |
Anti-Viral Drug Products |
Indium In-111 Pentate Disodium |
Radionuclide cisternography. |
Medical Imaging And Radiopharmaceutical Drug Products |
Indium In-111Oxyquinoline |
Radiolabeled autologous leukocytes for the detection of inflammatory process. |
Medical Imaging And Radiopharmaceutical Drug Products |
Insulin Aspart Recombinant |
Treatment of Type 1 diabetes. |
Metabolic And Endocrine Drug Products |
Iodixanol |
Radiographic contrast medium for purposes of angiography and arteriography. |
Medical Imaging And Radiopharmaceutical Drug Products |
Iofetamine I-123 |
Radioactive diagnostic-nonlacunar stroke. |
Medical Imaging And Radiopharmaceutical Drug Products |
Iopromide |
Aortography and visceral angiography coronary arteriography/left ventriculography. |
Medical Imaging And Radiopharmaceutical Drug Products |
Iotrolan |
Contrast enhancement for lumbar, thoracic, cervical and total columnar myelography of spinal and subarachnoid spaces. |
Medical Imaging And Radiopharmaceutical Drug Products |
Ioversol |
Radiopaque diagnostic (cerebral angiography and venography, cardiovascular angiography, contrast enhanced computed tomographic imaging of the head and body and excretory urography). |
Medical Imaging And Radiopharmaceutical Drug Products |
Ioxilan |
Computer enhanced computed tomographic imaging of head and body, aortofemoral arteriography, cerebral arteriography, ventriculography. |
Medical Imaging And Radiopharmaceutical Drug Products |
Ipratropium |
Symptomatic relief of rhinorrhea associated with perennial rhinitis. Common cold. |
Pulmonary Drug Products |
Irbesartan |
Hypertension. |
Cardio-Renal Drug Products |
Iron sucrose |
Iron deficiency anemia in chronic hemodialysis patients on erythropoietin. |
Gastrointestinal And Coagulation Drug Products |
Isoflurane |
Anesthesia. |
Anesthetic, Critical Care And Addiction Drug Products |
Isotretinoin |
Treatment of severe recalcitrant nodular acne. |
Dermatologic And Dental Drug Products |
Isradipine |
Hypertension. |
Cardio-Renal Drug Products |
Itraconazole |
Treatment of histoplasmosis and blastomycosis. Antifungal for the treatment of oropharyngeal candidiasis. |
Special Pathogen And Immunologic Drug Products |
Ketamine |
Induction of general anesthesia. Sedation in the intensive care unit. Rapid endotracheal intubation. Epidural pain control. Adjunct in pain management. Premedicant prior to surgery. Premedicant prior to or during a painful procedure. |
Anesthetic, Critical Care And Addiction Drug Products |
Ketoconazole |
Systemic fungal infections. |
Special Pathogen And Immunologic Drug Products |
Ketoconazole |
Dandruff. |
Over-The-Counter Drug Products |
Ketoconazole |
Topical cutaneous candidiasis. Treatment of dermatophytosis. Treatment of seborrheic dermatitis. |
Dermatologic And Dental Drug Products |
Ketoprofen |
Temporary relief of minor aches and pains associated with the common cold, headache, toothache, muscular aches, backache, minor pain of arthritis, menstrual cramps; temporary reduction of fever. |
Over-The-Counter Drug Products |
Ketorolac |
Analgesia, pain control. |
Anesthetic, Critical Care And Addiction Drug Products |
Ketorolac |
Treatment of ocular itching associated with allergic conjunctivitis. |
Anti-Inflammatory, Analgesic, And Ophthalmologic Drug Products |
Labetalol |
Hypertensive emergencies. |
Cardio-Renal Drug Products |
Lamivudine |
Treatment of Hepatitis B. Treatment of HIV infection. |
Anti-Viral Drug Products |
Lamotrigine |
Adjunctive therapy in patients with partial seizures. Conversion to monotherapy in patients with partial seizures who are receiving treatment with a single enzyme inducing anti-epileptic drug. |
Neuropharmacological Drug Products |
Lansoprazole |
Treatment of symptomatic GERD. Treatment of erosive esophagitis. |
Gastrointestinal And Coagulation Drug Products |
Leflunomide |
Juvenile rheumatoid arthritis. |
Anti-Inflammatory, Analgesic, And Ophthalmologic Drug Products |
Levalbuterol |
Treatment or prevention of bronchospasm in patients with reversible obstructive airway disease. |
Pulmonary Drug Products |
Levetiracetam |
Adjunctive therapy in treatment of partial onset seizures with or without secondary generalization in patients with epilepsy. |
Neuropharmacological Drug Products |
Levobetaxolol |
Lower intraocular pressure. |
Anti-Inflammatory, Analgesic, And Ophthalmologic Drug Products |
Levocabastine |
Temporary relief of the signs and symptoms of allergic conjunctivitis. |
Anti-Inflammatory, Analgesic, And Ophthalmologic Drug Products |
Levocarnitine |
Treatment of primary/secondary carnitine deficiency. |
Metabolic And Endocrine Drug Products |
Levofloxacin |
Community-acquired pneumonia. Complicated urinary tract infections. Complicated skin and skin structure infections. |
Special Pathogen And Immunologic Drug Products |
Linezolid |
Vancomycin-Resistant Enterococcus faecium infections, nosocomial pneumonia and complicated skin and skin structure infections. |
Anti-Infective Drug Products |
Lisinopril |
Hypertension. |
Cardio-Renal Drug Products |
Lithium |
Manic phase of bipolar disorder. |
Neuropharmacological Drug Products |
Loperamide |
Controls the symptoms of diarrhea, including travelers diarrhea. |
Over-The-Counter Drug Products |
Loperamide/ Simethicone |
Controls the symptoms of diarrhea and associated gas symptoms. |
Over-The-Counter Drug Products |
Lopinavir/Ritonavir |
Treatment of HIV infection. |
Anti-Viral Drug Products |
Loracarbef |
Pneumonia, sinusitis, UTI. Otitis media, skin and skin structure infections. |
Anti-Infective Drug Products |
Lorazepam |
Sedation during mechanical ventilation. As an anxiolytic. As a premedication prior to a procedure. |
Anesthetic, Critical Care And Addiction Drug Products |
Lorazepam |
Status epilepticus. Anxiety. |
Neuropharmacological Drug Products |
Losartan |
Hypertension. |
Cardio-Renal Drug Products |
Lovastatin |
Heterozygous familial hypercholesterolemia. |
Metabolic And Endocrine Drug Products |
Magnesium sulfate |
Hypertension. |
Cardio-Renal Drug Products |
Mangafodipir |
Indicated for the detection/classification/and diagnostic characterization of hepatic disease during magnetic resonance imaging (MRI). |
Medical Imaging And Radiopharmaceutical Drug Products |
Manganese |
Contrast agent for MRI of the abdomen and pelvis for delineation of the gastrointestinal tract. |
Medical Imaging And Radiopharmaceutical Drug Products |
Mannitol |
Diuresis. |
Cardio-Renal Drug Products |
Mebendazole |
Intestinal worm infestation. |
Special Pathogen And Immunologic Drug Products |
Mefloquine |
Treatment of mild to moderate acute malaria caused by Plasmodium falciparum or Plasmodium vivax. |
Special Pathogen And Immunologic Drug Products |
Meropenem |
Meningitis and intra-abdominal infections. |
Anti-Infective Drug Products |
Mesalamine |
Treatment of active ulcerative proctitis. Treatment of active mild to moderate distal ulcerative colitis, proctosigmoiditis, or proctitis. Induction of remission of ulcerative colitis. Maintenance of remission of ulcerative colitis. Treatment of ulcerative colitis. |
Gastrointestinal And Coagulation Drug Products |
Metaproterenol |
For treatment of asthma attacks and reversible bronchospasm. |
Pulmonary Drug Products |
Methotrexate |
Juvenile rheumatoid arthritis. |
Anti-Inflammatory, Analgesic, And Ophthalmologic Drug Products |
Methylclothiazide |
Hypertension. |
Cardio-Renal Drug Products |
Methyldopa |
Hypertension. |
Cardio-Renal Drug Products |
Methyldopate |
Hypertension. |
Cardio-Renal Drug Products |
Methylphenidate |
ADHD. |
Neuropharmacological Drug Products |
Metipranolol |
Lower intraocular pressure. |
Anti-Inflammatory, Analgesic, And Ophthalmologic Drug Products |
Metoclopramide |
Prevention of chemotherapy-induced emesis. Prevention of post-operative nausea and vomiting. Treatment of symptomatic GERD. |
Gastrointestinal And Coagulation Drug Products |
Metolazone |
Treatment of refractory edema. |
Cardio-Renal Drug Products |
Metoprolol |
Hypertension. |
Cardio-Renal Drug Products |
Metronidazole |
Anaerobic infections (intra-abdominal, skin and skin structure, gynecologic, bacterial septicemia, bone and joint, lower respiratory tract, and endocarditis). |
Special Pathogen And Immunologic Drug Products |
Mexiletine |
Arrhythmias. |
Cardio-Renal Drug Products |
Miconazole |
Fungal infections. |
Special Pathogen And Immunologic Drug Products |
Milrinone |
Treatment of heart failure. |
Cardio-Renal Drug Products |
Mirtazepine |
Treatment of depression. |
Neuropharmacological Drug Products |
Misoprostol |
Prevention of NSAID induced gastric ulcers in patients at high risk of complications. |
Gastrointestinal And Coagulation Drug Products |
Mivacurium |
Facilitate tracheal intubation. Provide skeletal muscle relaxation during surgery or mechanical ventilation. |
Anesthetic, Critical Care And Addiction Drug Products |
Modafanil |
Treatment of narcolepsy. |
Neuropharmacological Drug Products |
Moexipril |
Hypertension. |
Cardio-Renal Drug Products |
Mometasone |
Corticosteroid responsive dermatoses. |
Dermatologic And Dental Drug Products |
Mometasone |
Prophylaxis and treatment of seasonal allergic rhinitis and treatment of symptoms of perennial rhinitis. |
Pulmonary Drug Products |
Montelukast |
Prophylaxis and chronic treatment of asthma. |
Pulmonary Drug Products |
Morphine |
By epidural, caudal route for postoperative pain management. By continuous infusion in the critical care setting. As a premedicant prior to general anesthesia. By continuous or intermittent administration by patient controlled analgesia for acute or chronic pain syndromes. Subarachnoid for postoperative pain management. Intra-articular. Oral route for cancer pain. As an adjunct to general anesthesia prior to or during general anesthesia. |
Anesthetic, Critical Care And Addiction Drug Products |
Mupirocin |
Eradication of methicillin resistant S. aureus during institutional outbreaks. |
Anti-Infective Drug Products |
Nabumetone |
Juvenile rheumatoid arthritis. |
Anti-Inflammatory, Analgesic, And Ophthalmologic Drug Products |
Nadolol |
Hypertension. |
Cardio-Renal Drug Products |
Nafcillin |
Severe infections due to penicillinase producing staphylococci. |
Anti-Infective Drug Products |
Nalbuphine |
Treatment of nausea and itching from epidural opioids. Epidural pain management. As an adjunct to general anesthesia for postoperative pain management. Analgesia prior to or during a painful procedure. |
Anesthetic, Critical Care And Addiction Drug Products |
Naltrexone |
For treatment of opiate dependence. |
Anesthetic, Critical Care And Addiction Drug Products |
Naproxen Sodium |
Analgesia, antipyresis. |
Anti-Inflammatory, Analgesic, And Ophthalmologic Drug Products |
Naratriptan |
Acute treatment of migraine (with or without aura). |
Neuropharmacological Drug Products |
Nedocromil |
Maintenance therapy in the management of patients with mild to moderate asthma. |
Pulmonary Drug Products |
Nefazodone |
Treatment of depression. |
Neuropharmacological Drug Products |
Nelfinavir |
Treatment of HIV infection. |
Anti-Viral Drug Products |
Nevirapine |
Treatment of HIV infection. |
Anti-Viral Drug Products |
Nicardipine |
Hypertension. |
Cardio-Renal Drug Products |
Nicotine |
Temporary nicotine replacement for facilitating smoking cessation with or without a behavioral and/or psychological modification program. |
Anesthetic, Critical Care And Addiction Drug Products |
Nicotine |
To reduce withdrawal symptoms, including nicotine craving, associated with quitting smoking. |
Over-The-Counter Drug Products |
Nifedipine |
Hypertension. |
Cardio-Renal Drug Products |
Nisoldipine |
Hypertension. |
Cardio-Renal Drug Products |
Nitroglycerin |
Hypertension. |
Cardio-Renal Drug Products |
Nitroprusside |
Treatment of heart failure. Emergency use in hypertensive emergencies. |
Cardio-Renal Drug Products |
Nizatidine |
Erosive esophagitis. Treatment of symptomatic GERD. Treatment of ulcer disease. |
Gastrointestinal And Coagulation Drug Products |
Norfloxacin |
Complicated urinary tract infections. |
Special Pathogen And Immunologic Drug Products |
Norfloxacin |
Superficial infections of the eye caused by strains susceptible to norfloxacin. |
Anti-Inflammatory, Analgesic, And Ophthalmologic Drug Products |
Ofloxacin |
Treatment of ocular infections. |
Anti-Inflammatory, Analgesic, And Ophthalmologic Drug Products |
Olanzapine |
Management of the manifestations of psychotic disorders. |
Neuropharmacological Drug Products |
Olsalazine |
Maintenance of remission of ulcerative colitis in patients intolerant of sulfasalazine. |
Gastrointestinal And Coagulation Drug Products |
Omeprazole |
Treatment of symptomatic GERD. Treatment of erosive esophagitis. |
Gastrointestinal And Coagulation Drug Products |
Ondansetron |
Prevention of chemotherapy-induced emesis. Treatment of post-operative nausea and vomiting. Prevention of post-operative nausea and vomiting. |
Gastrointestinal And Coagulation Drug Products |
Orlistat |
Obesity management and reduction of the risk of weight gain. |
Metabolic And Endocrine Drug Products |
Oseltamivir |
Treatment of Influenza A and B. |
Anti-Viral Drug Products |
Oxacillin |
Infections due to penicillinase producing staphylococci. |
Anti-Infective Drug Products |
Oxazepam |
Anxiety. |
Neuropharmacological Drug Products |
Oxcarbazepine |
Adjunctive therapy in treatment of partial seizures with or without secondary generalization in patients with epilepsy. |
Neuropharmacological Drug Products |
Oxycodone |
Management of pain. |
Anesthetic, Critical Care And Addiction Drug Products |
Pancrelipase |
Chronic pancreatitis. |
Gastrointestinal And Coagulation Drug Products |
Pancuronium |
Neuromuscular blocking agent. |
Anesthetic, Critical Care And Addiction Drug Products |
Pantoprazole |
Short-term treatment of erosive esophagitits associated with GERD. |
Gastrointestinal And Coagulation Drug Products |
Paricalcitol |
Prevention and treatment of secondary hyperparathyroidism associated with chronic renal failure. |
Metabolic And Endocrine Drug Products |
Paroxetine |
Treatment of depression. Obsessive compulsive disorder. |
Neuropharmacological Drug Products |
Pemoline |
ADHD. |
Neuropharmacological Drug Products |
Penbutolol |
Hypertension. |
Cardio-Renal Drug Products |
Penciclovir |
Recurrent herpes labialis. |
Anti-Viral Drug Products |
Pentamadine |
Prevention of Pneumocystis carnii infection. |
Special Pathogen And Immunologic Drug Products |
Perindopril |
Hypertension. |
Cardio-Renal Drug Products |
Permethrin |
Treatment of pediculus humanus capitis (head lice) infestation. |
Over-The-Counter Drug Products |
Phentolamine |
Hypertension. |
Cardio-Renal Drug Products |
Pimozide |
Tourettes. |
Neuropharmacological Drug Products |
Pindolol |
Hypertension. |
Cardio-Renal Drug Products |
Piperacillin |
Severe infections, including intra-abdominal, UTI, respiratory, skin, bone and joint, and gonococcal infections. |
Anti-Infective Drug Products |
Piperacillin/ Tazobactam |
Appendicitis (complicated by rupture/abscess), peritonitis, community-acquired pneumonia, hospital acquired pneumonia, skin and skin structure infections. |
Anti-Infective Drug Products |
Pirbuterol |
Prevention and reversal of bronchospasm. |
Pulmonary Drug Products |
Polyethylene glycol-containing elecrolyte solutions |
Bowel cleansing prior to colonoscopy and/or barium enema x-ray examination. |
Gastrointestinal And Coagulation Drug Products |
Polythiazide |
Hypertension. |
Cardio-Renal Drug Products |
Pralidoxime |
For treatment of poisoning due to pesticides/chemicals of the organophosphate class. |
Neuropharmacological Drug Products |
Pravastatin |
Heterozygous familial hypercholesterolemia. |
Metabolic And Endocrine Drug Products |
Praziquantel |
Infections due to all species of Schistosoma. Infections due to the liver flukes, Chlonorchis sinensis, Opisthorchis viverrini. |
Special Pathogen And Immunologic Drug Products |
Prazosin |
Hypertension. |
Cardio-Renal Drug Products |
Procainamide |
Arrhythmias. |
Cardio-Renal Drug Products |
Propafenone |
Treatment of life threatening ventricular arrhythmias. Prolonging the time to recurrence of supraventricular tachycardia. |
Cardio-Renal Drug Products |
Propranolol |
Hypertension. |
Cardio-Renal Drug Products |
Pseudoephedrine |
Nasal decongestant, colds, sinus and allergy congestion. |
Over-The-Counter Drug Products |
Pyrazinamide |
Treatment of tuberculosis. |
Special Pathogen And Immunologic Drug Products |
Quaternium-18 |
Protects against poison ivy, poison oak, and poison sumac rash when applied before exposure. |
Over-The-Counter Drug Products |
Quetiapine |
Management of the manifestations of psychotic disorders. |
Neuropharmacological Drug Products |
Quinapril |
Treatment of heart failure. Hypertension. |
Cardio-Renal Drug Products |
Quinethazone |
Hypertension. |
Cardio-Renal Drug Products |
Quinidine |
Prolonging the time to recurrence of supraventricular tachycardia. Treatment of life threatening ventricular arrhythmias. Conversion of atrial fibrillation and flutter to normal sinus rhythm. |
Cardio-Renal Drug Products |
Quinupristin/Dalfopristin |
Vancomycin-Resistant Enterococcus faecium infections. |
Anti-Infective Drug Products |
Rabeprazole |
Treatment of gastric/duodenal ulcers, GERD maintenance and Zollinger-Ellison Syndrome. |
Gastrointestinal And Coagulation Drug Products |
Ramipril |
Hypertension. |
Cardio-Renal Drug Products |
Ranitidine bismuth citrate |
Healing and prevention of duodenal ulcer relapse due H pylori infection when used in conjunction with clarithromycin. |
Special Pathogen And Immunologic Drug Products |
Rapacuronium |
Adjunct to general anesthesia to facilitate tracheal intubation and provide skeletal muscle relaxation. |
Anesthetic, Critical Care And Addiction Drug Products |
Repaglinide |
Type 2 Diabetes. |
Metabolic And Endocrine Drug Products |
Reserpine |
Hypertension. |
Cardio-Renal Drug Products |
Ribavirin/Interferon alpha-2b |
Treatment of Chronic Hepatitis C in patients with compensated liver disease previously untreated with alpha interferon or who have relapsed following alpha interferon therapy. |
Anti-Viral Drug Products |
Rifampin |
Meningococcal carrier state. Tuberculosis. |
Special Pathogen And Immunologic Drug Products |
Rifampin/Isoniazid/ Pyrazinamide |
Pulmonary tuberculosis. |
Special Pathogen And Immunologic Drug Products |
Rifapentine |
Pulmonary tuberculosis. |
Special Pathogen And Immunologic Drug Products |
Rimantadine |
Prophylaxis and treatment of illness caused by influenza virus. |
Anti-Viral Drug Products |
Rimexolone |
Uveitis. |
Anti-Inflammatory, Analgesic, And Ophthalmologic Drug Products |
Risperidone |
Manifestations of psychotic disorders. |
Neuropharmacological Drug Products |
Ritonavir |
Treatment of HIV infection. |
Anti-Viral Drug Products |
Rizatriptan |
Acute treatment of migraine (with and without aura). |
Neuropharmacological Drug Products |
Rocuronium |
Nondepolarizing neuromuscular blocking agent. Intramuscular administration to facilitate endotracheal intubation when intravenous access is not available. |
Anesthetic, Critical Care And Addiction Drug Products |
Rofecoxib |
Short term treatment of pain |
Anti-Inflammatory, Analgesic, And Ophthalmologic Drug Products |
Ropivacaine |
Production of local or regional anesthesia. |
Anesthetic, Critical Care And Addiction Drug Products |
Rosiglitazone |
Type 2 Diabetes. |
Metabolic And Endocrine Drug Products |
Rubidium Rb-82 Chloride |
To access regional myocardial perfusion in the diagnosis and localization of myocardial infarction. |
Medical Imaging And Radiopharmaceutical Drug Products |
Salmeterol |
For long term daily use in the maintenance and treatment of asthma and prevention of bronchospasm. |
Pulmonary Drug Products |
Saquinavir |
Treatment of HIV infection. |
Anti-Viral Drug Products |
Scopolamine |
Motion sickness. |
Neuropharmacological Drug Products |
Sertraline |
Obsessive compulsive disorder. Treatment of depression. |
Neuropharmacological Drug Products |
Sevelamer |
Phosphate binding in end stage renal disease. |
Metabolic And Endocrine Drug Products |
Silver Sulfadiazine |
Treatment of burns. |
Anti-Infective Drug Products |
Simethicone Coated Cellulose |
Enhance the delineation of upper abdominal anatomy in conjunction with ultrasound imaging. |
Medical Imaging And Radiopharmaceutical Drug Products |
Simvastatin |
Heterozygous familial hypercholesterolemia. |
Metabolic And Endocrine Drug Products |
Sirolimus |
Prophylaxis of organ rejection in patients receiving renal transplant. |
Special Pathogen And Immunologic Drug Products |
Sodium Iodide I-123 |
Indicated for the use in the evaluation of thyroid function and/or morphology. |
Medical Imaging And Radiopharmaceutical Drug Products |
Sodium Iodide I-131 |
Therapeutic for the treatment of hyperthyroidism and selected cases of carcinoma of the thyroid. |
Medical Imaging And Radiopharmaceutical Drug Products |
Sodium phosphate |
Laxative. |
Over-The-Counter Drug Products |
Somatropin Recombinant |
Failure to thrive in AIDS patients |
Metabolic And Endocrine Drug Products |
Spirapril |
Hypertension. |
Cardio-Renal Drug Products |
Spironolactone |
Hypertension. |
Cardio-Renal Drug Products |
Stavudine |
Treatment of HIV infection. |
Anti-Viral Drug Products |
Sulfasalazine |
Maintenance of remission of ulcerative colitis. |
Gastrointestinal And Coagulation Drug Products |
Sulfasalazine |
Treatment of juvenile rheumatoid arthritis in patients who have had an inadequate response to salicylates or other NSAIDs. |
Anti-Inflammatory, Analgesic, And Ophthalmologic Drug Products |
Sulfonylurea agents |
Type 2 Diabetes. |
Metabolic And Endocrine Drug Products |
Sumatriptan |
Acute treatment of migraine (with or without aura). |
Neuropharmacological Drug Products |
Talc |
Treatment of malignant pleural effusion. |
Oncology Drug Products |
Technetium Tc-99m Albumin Aggregated |
Scintigraphic imaging of the lungs as an adjunct to other diagnostic procedures whenever information about pulmonary circulation is needed. |
Medical Imaging And Radiopharmaceutical Drug Products |
Technetium Tc-99m Apcitide |
Scintigraphic imaging of acute venous thrombosis in the lower extremities in patients who have signs and symptoms of acute venous thrombosis. |
Medical Imaging And Radiopharmaceutical Drug Products |
Technetium Tc-99m Bicisate |
Adjunct to conventional CT or MRI imaging in the localization of stroke in patients in whom stroke has already been diagnosed. |
Medical Imaging And Radiopharmaceutical Drug Products |
Technetium Tc-99m Disofenin |
Hepatobiliary imaging agent. |
Medical Imaging And Radiopharmaceutical Drug Products |
Technetium Tc-99m Exametazime |
Radioactive diagnostic (altered regional cerebral perfusion in stroke). |
Medical Imaging And Radiopharmaceutical Drug Products |
Technetium Tc-99m Lidofenin |
Hepatobiliary imaging agent. |
Medical Imaging And Radiopharmaceutical Drug Products |
Technetium Tc-99m Mebrofenin |
Radioactive diagnostic for hepatobiliary imaging. |
Medical Imaging And Radiopharmaceutical Drug Products |
Technetium Tc-99m Medronate |
Bone imaging agent to delineate areas of altered osteogenesis. |
Medical Imaging And Radiopharmaceutical Drug Products |
Technetium Tc-99m Pentetate |
Used to perform kidney imaging, brain imaging, to assess renal perfusion and to estimate glomerular filtration rate. |
Medical Imaging And Radiopharmaceutical Drug Products |
Technetium Tc-99m Red Blood Cell |
Blood pool imaging including cardiac first pass and gated equilibrium imaging and for the detection of sites of gastrointestinal bleeding. |
Medical Imaging And Radiopharmaceutical Drug Products |
Technetium Tc-99m Sestamibi |
Myocardial perfusion imaging agent that is indicated for detecting coronary artery disease. |
Medical Imaging And Radiopharmaceutical Drug Products |
Technetium Tc-99m Sodium Gluceptate |
Used to image kidney and brain, and to assess renal and brain perfusion. |
Medical Imaging And Radiopharmaceutical Drug Products |
Technetium Tc-99m Succimer |
Evaluation of renal parenchymal disorders. |
Medical Imaging And Radiopharmaceutical Drug Products |
Technetium Tc-99m Teboroxime |
Myocardial perfusion agent useful in distinguishing normal from abnormal myocardium in patients with suspected coronary artery disease using rest and stress techniques. |
Medical Imaging And Radiopharmaceutical Drug Products |
Technetium Tc-99m Tetrofosmin |
Useful for the scintigraphic imaging of the myocardium following separate administrations under exercise and resting conditions for the delineation of regions of reversible myocardial ischemia in the presence or absence of infarcted myocardium. |
Medical Imaging And Radiopharmaceutical Drug Products |
Telmisartan |
Hypertension. |
Cardio-Renal Drug Products |
Temozolomide |
Treatment of recurrent glioma/advanced metastatic melanoma |
Oncology Drug Products |
Terazosin |
Hypertension. |
Cardio-Renal Drug Products |
Terbinafine |
Topical treatment of tinea cruris caused by Trichophyton rubrum, Epidermophyton floccisum, or Trichophyton entagrophytes. Topical treatment of tinea corporis caused by Trichophyton rubrum, Epidermophyton floccisum, or Trichophyton entagrophytes. Topical treatment of tinea pedis caused by Trichophyton rubrum, Epidermophyton floccisum, or Trichophyton entagrophytes. |
Dermatologic And Dental Drug Products |
Terbutaline |
Prevention and reversal of bronchospasm. |
Pulmonary Drug Products |
Terconazole |
Vaginal candidiasis. |
Special Pathogen And Immunologic Drug Products |
Thiabendazole |
Treatment of Trichinosis. Second line agent in Uncinariasis (hookworm: Necator americanus and Ancylostoma duodenale), Trichuriasis (whipworm), and Ascariasis (large roundworm). Treatment of Strongyloidiasis (threadworm). Treatment of Cutaneous larva migrans (creeping eruption). |
Special Pathogen And Immunologic Drug Products |
Tiagabine |
Adjunctive therapy for partial seizures with and without secondary generalization. |
Neuropharmacological Drug Products |
Ticarcillin/Clavulanate |
Septicemia, skin and skin structure infections, lower respiratory, UTI, and intra-abdominal infections. |
Anti-Infective Drug Products |
Timolol |
Lowering intraocular pressure in patients with chronic open-angle glaucoma, aphakic glaucoma, secondary glaucoma, other patients with elevated intraocular pressure. |
Anti-Inflammatory, Analgesic, And Ophthalmologic Drug Products |
Tinzaparin |
Treatment of deep venous thrombosis. |
Gastrointestinal And Coagulation Drug Products |
Tizanidine |
Management of spasticity. |
Neuropharmacological Drug Products |
Tolmetin |
Juvenile rheumatoid arthritis. |
Anti-Inflammatory, Analgesic, And Ophthalmologic Drug Products |
Topiramate |
Adjunctive therapy in patients with partial onset seizures with or without secondarily generalized seizures. |
Neuropharmacological Drug Products |
Torsemide |
Hypertension. Treatment of edema (CHF, liver or kidney disease). |
Cardio-Renal Drug Products |
Tramadol |
Management of acute and chronic pain. |
Anti-Inflammatory, Analgesic, And Ophthalmologic Drug Products |
Trandolpril |
Hypertension. |
Cardio-Renal Drug Products |
Trazodone |
Treatment of depression. |
Neuropharmacological Drug Products |
Triamcinolone |
For the treatment of seasonal and perennial rhinitis symptoms. For patients who require chronic treatment with corticosteroids for control of the symptoms of bronchial asthma. |
Pulmonary Drug Products |
Triamterene |
Hypertension. |
Cardio-Renal Drug Products |
Trichlormethiazide |
Hypertension. |
Cardio-Renal Drug Products |
Trimethoprim |
Urinary tract infection. |
Anti-Infective Drug Products |
Valacyclovir |
Treatment of initial and recurrent episodes of genital herpes and herpes zoster. Prophylaxis of genital herpes. |
Anti-Viral Drug Products |
Valproate |
Mania. Migraine prevention. Therapy in simple (petit mal) & complex absence seizures & multiple seizure types. |
Neuropharmacological Drug Products |
Valsartan |
Hypertension. |
Cardio-Renal Drug Products |
Venlafaxine |
Treatment of depression. Generalized Anxiety Disorder. |
Neuropharmacological Drug Products |
Verapamil |
For rapid control of ventricular arrhythmia in the face of supraventricular tachycardia. |
Cardio-Renal Drug Products |
Vercuronium |
Neuromuscular blockade. |
Anesthetic, Critical Care And Addiction Drug Products |
Xenon Xe-133 |
Evaluation of pulmonary function and for imaging of the lungs and the assessment of cerebral blood flow. |
Medical Imaging And Radiopharmaceutical Drug Products |
Zafirlukast |
Prophylaxis and chronic treatment of asthma. |
Pulmonary Drug Products |
Zalcitabine |
Treatment of HIV infection. |
Anti-Viral Drug Products |
Zanamivir |
Treatment of Influenza A and B. |
Anti-Viral Drug Products |
Zolmitriptan |
An oral agent for the acute treatment of migraine attacks with or without aura. |
Neuropharmacological Drug Products |
Zonisamide |
As adjunctive therapy in the treatment of partial seizures in patients with epilepsy. |
Neuropharmacological Drug Products |
Product Name |
Indication |
CBER Office |
Anthrax Vaccine |
Prevention of anthrax. |
Vaccine Research and Review |
Antithrombin III |
Hereditary antithrombin III deficiency. |
Therapeutics Research and Review |
Botulinum Toxin Type A |
Strabismus and blepharospasm. |
Vaccine Research and Review |
Cytomegalovirus Immune Globulin Intravenous |
Prevention of CMV disease in AIDS. |
Blood Research and Review |
Dacluzimab |
Renal allograft rejection. |
Therapeutics Research and Review |
GM-CSF, Sargramostim |
PBPC mobilization. |
Therapeutics Research and Review |
Hepatitis A Vaccine |
Prevention of Hepatitis A. |
Vaccine Research and Review |
Infliximab |
Rheumatoid Arthritis. Moderate to severely active Crohn's Disease. Fistulizing Crohn's Disease. |
Therapeutics Research and Review |
Interferon alfacon |
Hepatitis C. |
Therapeutics Research and Review |
Interferon-alpha 1b |
Hepatitis C. |
Therapeutics Research and Review |
Interferon-alpha n-1 |
Hepatitis C. |
Therapeutics Research and Review |
Lymphocyte Immune Globulin, Anti-thymocyte Globulin |
Prevention of allo-transplant rejection. |
Blood Research and Review |
Peginterferon alfa-2b |
Treatment of Hepatitis C. |
Therapeutics Research and Review |
FDA/Center for Drug Evaluation and Research
Last Updated: May 22, 200119 Jan 2006 11:14:24 -0500
Originator: OTCOM/DLIS
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