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What's New by Date
This page lists new and revised documents posted to the CDER web
site. Each listing will remain on this page approximately 30 days. The dates listed
indicate the dates of posting to the CDER web site, not the dates of origination or
revision. When viewing a document, click your browser's "refresh" or "reload" button to
make sure you are seeing the latest version.
View New Items by Category
January 16, 2009
- FDA Public Health Advisory Potential Hazards of Skin Products Containing Numbing Ingredients for Relieving Pain from Mammography and Other Medical Tests and Conditions. Information
- Guidance for Industry:
- Animal Models — Essential Elements to Address Efficacy Under the Animal Rule [PDF]
- Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act [PDF]
- National Drug Code Directory
- New and Generic Drug Approvals
- Amoxicillin Tablets, DAVA Pharmaceuticals, Inc., Approval
- Levetiracetam Oral Solution, Roxane Laboratories, Inc., Approval
- Levetiracetam Oral Solution, TOLMAR Inc., Approval
- Levetiracetam Tablets, Aurobindo Pharma, Inc., Approval
- Levetiracetam Tablets, Cobalt Laboratories, Inc., Approval
- Levetiracetam Tablets, Dr. Reddy’s Laboratories Limited, Approval
- Levetiracetam Tablets, Lupin Limited, Approval
- Levetiracetam Tablets, Orchid Healthcare, Approval
- Levetiracetam Tablets, Roxane Laboratories, Inc., Approval
- Levetiracetam Tablets, Sandoz Inc., Approval
- Levetiracetam Tablets, Torrent Pharmaceuticals Limited, Approval
January 15, 2009
January 14, 2009
- Guidance for Industry:
- Guidance for Clinical Investigators,
Sponsors, and IRBs
Adverse Event Reporting to IRBs —
Improving Human Subject Protection [PDF] or [HTML]
- Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices U.S.[HTML]
- Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)
- Meeting Summary: Drug Safety Oversight Board Off-Site, December 18, 2008
- New and Generic Drug Approvals
- Folic Acid Tablets, Excellium Pharmaceutical, Inc., Approval
- Humatrope (somatropin [rDNA origin]) Injection, Eli Lilly and Co., Control Supplement
- Isentress (raltegravir potassium) Tablets, Merck & Co., Inc., Labeling Revision
- Lithium Carbonate Capsules, Kendle Regulatory Affairs, Approval
- Survanta (beractant) Intratracheal Suspension, Abbott Laboratories, Labeling Revision
January 13, 2009
- BPCA/Pediatric Exclusivity Statistics (updated)
- Drugs Shortages: Resolved Drug Shortages; Albuterol Metered Dose Inhalers and Levalbuterol Metered Dose Inhalers
- Follow-up to the March 27, 2008, Communication about the Ongoing Safety Review of Montelukast (Singulair) Information
- Inactive Ingredient Search for Approved Drug Products (updated)
- New and Generic Drug Approvals
- Alprazolam Orally Disintegrating Tablets, Kali Laboratories, Inc., Approval
- Venlafaxine Hydrochloride Tablets, Actavis Totowa LLC, Approval
- Zingo (lidocaine hydrochloride) Intradermal System, Anesiva, Inc., Patient Population Altered
- Office of Generic Drugs: List of Authorized Generic Drugs (updated)
January 12, 2009
January 9, 2009
- AAPS Workshop; Utilization of Process Modeling & Advanced Process Control in QbD Based Drug Development and Manufacturing, April 27-28, 2009, Sheraton Inner Harbor Hotel, Baltimore, MD. Meeting Information
- FDA Data Standards Manual: Drug Nomenclature Monograph (updated)
- New and Generic Drug Approvals
- Alfuzosin Hydrochloride Extended-Release Tablets, TEVA Pharmaceuticals USA, Tentative Approval
- Tri-Nasal (triamcinolone acetonide) Nasal Spray, Collegium Pharmaceutical, Control Supplement
- Ciclopirox Gel, Paddock Laboratories, Inc., Approval
- Genotropin (somatropin recombinant) Injection, Pharmacia & Upjohn Co., Control Supplement
- Nicardipine Hydrochloride Injection, Teva Parenteral Medicines, Labeling Revision
- Stavudine Capsules, Matrix Laboratories, Ltd., Approval
- Vytorin (ezetimibe and simvastatin) Tablets, MSP Singapore Company, LLC, Labeling Revision
- Office of Nonprescription Products: Rulemaking History for Nonprescription Products (updated)
January 8, 2009
January 7, 2009
- Drugs@FDA Downloadable Data Files (updated)
- Investigational Human Drugs: Clinical Investigator Inspection List (updated)
- New and Generic Drug Approvals
- ActoPlus Met (pioglitazone hydrochloride and metformin hydrochloride) Tablets, Takeda Global Research & Development Center, Inc., Labeling Revision
- Celebrex (celecoxib) Capsules, Pfizer Inc., New Dosage Regimen
- Duetact (pioglitazone hydrochloride and glimepiride) Tablets, Takeda Global Research & Development Center, Inc., Labeling Revision
- Eldepryl (selegiline hydrochloride) Tablets, Somerset Pharmaceuticals, Inc., Labeling Revision
- Etomidate Injection, Ebewe Parenta Pharmaceuticals, Inc., Approval
- Protopic (tacrolimus) Ointment, Astellas Pharma US, Inc., Manufacturing Change or Addition
- Requip (ropinirole hydrochloride) Tablets, GlaxoSmithKline, Labeling Revision
- Sinemet (carbidopa and levodopa) Tablets, Bristol-Myers Squibb Co., Labeling Revision
- Sinemet CR (carbidopa and levodopa) Extended-ReleaseTablets, Bristol-Myers Squibb Co., Labeling Revision
- Symmetrel (amantadine hydrochloride) Syrup, Endo Pharmaceuticals, Inc., Labeling Revision
January 6, 2009
- Division of Drug Marketing, Advertising, and Communications - Research (updated)
- New and Generic Drug Approvals
- Abacavir Sulfate and Lamivudine Tablets, Aurobindo Pharma Ltd., Tentative Approval
- Coreg (carvedilol) Tablets, GlaxoSmithKline, Labeling Revision
- Coreg CR (carvedilol phosphate) Extended-Release Capsules, GlaxoSmithKline, Approval
- Casodex (bicalutamide) Tablets, AstraZeneca Pharmaceuticals LP, Approval
- Dianeal Pd-1 w/ Dextrose 2.5% in Plastic Container (calcium chloride, dextrose, magnesium chloride, sodium chloride and sodium lactate) Intraperitoneal Solution, Baxter Healthcare Corp., Labeling Revision
- Geodon (ziprasidone meyslate) Intramuscular Injection, Pfizer, Inc., Manufacturing Change or Addition
- Lotrisone (clotrimazole and betamethasone dipropionate) Lotion, Schering-Plough, Labeling Revision
- Mirapex (pramipexole dihydrochloride) Tablets, Boehringer Ingelheim Pharmaceuticals, Inc., Labeling Revision
- Prezista (darunavir ethanolate) Tablets, Tibotec, Inc., Patient Population Altered
- Reclast (zoledronic acid) I.V. Injection, Novartis Pharmaceuticals Corp., New or Modified Indication
- Sensipar (cinacalcet hydrochloride) Tablets, Amgen Inc., Labeling Revision
- Xolegel (ketoconazole) Gel, Barrier Therapeutics, Inc., Package Change
- Zelapar (selegiline hydrochloride) Orally Disintegrating Tablets, Valeant Pharmaceuticals International, Labeling Revision
- Ziagen (abacavir sulfate) Oral Solution, GlaxoSmithKline, Labeling Revision
- Ziagen (abacavir sulfate) Tablets, GlaxoSmithKline, New Dosage Regimen
- Zolpimist (zolpidem tartrate) Inhalation Spray, NovaDel Pharma, Inc., Approval
January 5, 2009
- On Dec. 31, 2008, Celgene issued a Dear Healthcare Professional letter describing a controlled clinical study suggesting that Innohep may increase the risk for death, compared to unfractionated heparin when used to treat elderly patients with renal insufficiency. MedWatch Safety Alert
- Guidance for Industry:
- Paragraph IV Patent Certifications (updated)
January 2, 2009
- Guidance for Industry: Labeling OTC Human Drug Products -- Questions and Answers [PDF]
- New and Generic Drug Approvals
- Avinza (morphine sulfate) Extended-Release Capsules, King Pharmaceuticals, Inc., Control Supplement
- Diltiazem Hydrochloride Injection, Baxter Healthcare Corp., Approval
- Fludarabine Phosphate (fludarabine phosphate) Tablets, Antisoma, Approval
- Fluoxetine Hydrochloride Delayed-Release Capsules, Dr. Reddy's Laboratories, Ltd., Tentative Approval
- Gemcitabine Hydrochloride Injection, TEVA Parenteral Medicines, Inc., Approval
- Infuvite Pediatric (ascorbic acid, biotin, cholecalciferol, cyanocobalamin, dexpanthenol, folic acid, niacinamide, pyridoxine, riboflavin, thiamine, tocopherol acetate, vitamin A and vitamin K), Sandoz Canada, Inc., Control Supplement
- Levetiracetam Tablets, Cobalt Laboratories, Inc., Tentative Approval
- Malarone (atovaquone and proguanil hydrochloride) Tablets, GlaxoSmithKline, Labeling Revision
- Proglycem (diazoxide) Oral Suspension, Teva Global Respiratory Research, LLC, Manufacturing Change or Addition
- Promethazine Hydrochloride Tablets, Sun Pharmaceutical Industries, Inc., Approal
- Rifater (isoniazid, pyrazinamide and rifampin) Tablets, Sanofi-aventis U.S. LLC, Labeling Revision
- Ryzolt (tramadol hydrochloride) Extended-Release Tablets, Labopharm Canada, Inc., Approval
- Trilipix (fenofibric acid) Delayed-Release Capsules, Abbott Laboratories, Approval
- Vancomycin Hydrochloride Injection, Akorn - Strides, LLC, Approval
- Vasovist (gadofosveset trisodium) Injection, Epix Pharmaceuticals, Approval
December 31, 2008
- Drugs@FDA Downloadable Data Files (updated)
- New and Generic Drug Approvals
- Acetadote (acetylcysteine) Intravenous Injection, Cumberland Pharmaceuticals Inc., Labeling Revision
- Alvesco (ciclesonide) Inhalation Aerosol, Sepracor, Inc., Labeling Revision
- Aromasin (exemestane) Tablets, Pfizer Inc., Labeling Revision
- Bicalutamide Tablets, Accord Healthcare Inc., USA, Tentative Approval
- Butalbital, Acetaminophen and Caffeine Tablets, Concord Laboratories, Inc., Approval
- Cyklokapron (tranexamic acid) Injection, Pfizer Inc., Labeling Revision
- Emtricitabine Capsules, Matrix Laboratories Ltd., Approval
- Enalaprilat Injection, Hikma Farmaceutica (Portugal), Approval
- Famvir (famciclovir) Tablets, Novartis Pharmaceuticals Corporation, Labeling Revision
- Follistim AQ (follitropin alfa and beta) Injection, Organon USA Inc., Package Change
- Hydrocodone Bitartrate and Acetaminophen Tablets, Sun Pharmaceutical Industries, Inc., Approval
- Ibuprofen and Diphenhydramine Citrate Tablets, Perrigo R&D Company, Approval
- Irinotecan Hydrochloride Injection, Bedford Laboratories, Approval
- Latisse (bimatoprost) Ophthalmic Solution, Allergan, Inc., Approval
- Letrozole Tablets, Mylan Pharmaceuticals, Inc., Approval
- Meridia (sibutramine hydrochloride) Capsules, Abbott Laboratories, Labeling Revision
- Nexterone (amiodarone hydrochloride) Injection, Prism Pharmaceuticals, Inc., Approval
- Pamidronate Disodium Injection, GeneraMedix Inc., Approval
- Pamidronate Disodium Injection, Sun Pharmaceutical Industries, Ltd., Approval
- Quetiapine Fumarate Tablets, Teva Pharmaceuticals USA, Tentative Approval
December 30, 2008
- Designating Additions to the Current List of Tropical Diseases in the Food and Drug Administration Amendments Act; Public Hearing, 12/12/2008; Presentations
- Drug Firm Annual Registration Status (updated)
- New and Generic Drug Approvals
- Avelox (moxifloxacin hydrochloride) Tablets, Bayer HealthCare Pharmaceuticals Inc., Labeling Revision
- Avelox in Sodium Chloride 0.8% in Plastic Container (moxifloxacin hydrochloride) I.V. Injection, Bayer HealthCare Pharmaceuticals Inc., Labeling Revision
- Desogestrel, Ethinylestradiol and Ethinyl Estradiol Tablets, Watson Laboratories, Inc., Approval
- Fuzeon (enfuvirtide) Subcutaneous Injection, Hoffmann-La Roche, Inc., Labeling
Revision
- Gemfibrozil Tablets, Sun Pharmaceutical Industries, Inc., Approval
- Glycopyrrolate Tablets, Vintage Pharmaceuticals, Approval
- Innohep (tinzaparin sodium) Injection, Celgene Corporation, Labeling Revision
- Nicotine Polacrilex, Gum, Watson Laboratories, Inc., Approval
- Nicotine Polacrilex Gum, Watson Laboratories, Inc., Approval
- Risperidone Tablets, Vintage Pharmaceuticals, LLC, Approval
- Rocuronium Bromide Injection, APP Pharmaceuticals, LLC, Approval
- Stavudine Capsules, Hetero Drugs Ltd., Approval
- Stavudine Capsules, Matrix Laboratories, Inc., Approval
- Stavudine Capsules, Aurobindo Pharma Ltd., Approval
- Stavudine Oral Solution, Aurobindo Pharma Ltd., Approval
- Vecuronium Bromide Injection, GeneraMedix Inc., Approval
- Ziprasidone Hydrochloride Capsules, Dr. Reddy’s Laboratories Ltd., Tentative Approval
December 29, 2008
December 24, 2008
December 23, 2008
December 22, 2008
December 19, 2008
- New and Generic Drug Approvals
- Albuterol Sulfate Inhalation Solution, Lannett, Approval
- Cellcept (mycophenolate mofetil) Capsules, Roche Palo Alto LLC, Labeling Revision
- Cellcept (mycophenolate mofetil) Tablets, Roche Palo Alto LLC, Labeling Revision
- Cellcept (mycophenolate mofetil hydrochloride) Injection, Roche Palo Alto LLC, Labeling Revision
- Cellcept (mycophenolate mofetil) Oral Suspension, Roche Palo Alto LLC, Labeling Revision
- Enablex (darifenacin hydrobromide) Extended-Release Tablets, Novartis Pharmaceuticals Corp., Labeling Revision
- Myfortic (mycophenolic acid) Delayed-Release Tablets, Novartis Pharmaceuticals Corp., Labeling Revision
- Naproxen Sodium Tablets, Amneal Pharmaceuticals LLC, Approval
- Toradol (ketorolac tromethamine) Tablets, Hoffmann-La Roche Inc., Labeling Revision
- CDER Organization Charts [HTML] [PDF] (updated)
December 18, 2008
- New and Generic Drug Approvals
- Galantamine Hydrobromide Extended-Release Capsules, Watson Laboratories, Inc., Approval
- Genotropin (somatropin recombinant) Injection, Pharmacia & Upjohn, Labeling Revision
- Hydralazine Hydrochloride Tablets, Invagen Pharmaceuticals, Inc., Approval
- Infuvite Pediatric (Pharmacy Bulk Package) (ascorbic acid, biotin, cholecalciferol, cyanocobalamin, dexpanthenol, folic acid, niacinamide, pyridoxine, riboflavin, thiamine, tocopherol acetate, vitamin A and vitamin K) I.V. Injection, Sandoz Canada, Inc., Control Supplement
- Integrilin (eptifibatide) Injection, Schering Corp., Labeling Revision
- Mozobil (plerixafor) Injection, Genzyme Corp., Approval
- Trilipix (fenofibric acid) Delayed-Release Capsules, Abbott Laboratories, Approval
- Ursodiol Capsules, Lannett Holdings, Inc., Approval
- Office of Generic Drugs: Determination of Dorzolamide-Timolol Maleate Ophthalmic Solution Exclusivitiy
December 17, 2008
- Drugs@FDA Downloadable Data Files (updated)
- Guidance for Industry: Diabetes Mellitus -- Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes [PDF] or [HTML]
- Guidance for Industry: Orally Disintegrating Tablets [PDF]
- New and Generic Drug Approvals
- Acetadote (acetylcysteine) Injection, Cumberland Pharmaceuticals, Inc., Labeling Revision
- Aredia (pamidronate disodium) Injection, Novartis Pharmaceuticals Corp., Labeling Revision
- Efavirenz Tablets, Aurobindo Pharma Ltd., Tentative Approval
- Enablex (darifenacin hydrobromide) Extended-Release Tablets, Novartis Pharmaceuticals Corp., Labeling Revision
- Lusedra (fospropofol disodium) Injection, Eisai Medical Research Inc., Approval
- Omnicef (cefdinir) Capsules, Abbott Laboratories, Labeling Revision
- Omnicef (cefdinir) Oral Suspension, Abbott Laboratories, Labeling Revision
- Office of Nonprescription Products: Rulemaking History for Nonprescription Products (updated)
December 16, 2008
December 15, 2008
- Division of Drug Marketing,
Advertising, and Communications Letter: Xodol (hydrocodone bitartrate and acetaminophen) tablets
- Guidance for Industry:
- Postmarketing Adverse Even Reporting for Medical products and Dietary Supplements During an Influenza Pandemic [PDF] or [HTML]
- Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches [PDF] or [HTML]
- Bioequivalence Guidance: 17 new recommendations have been added, including Vancomycin [PDF]
- New and Generic Drug Approvals
- Actos (pioglitazone hydrochloride) Tablets, Takeda Global Research & Development Center, Inc., Labeling Revision
- Calcitonin Salmon Nasal Spray, Nastech Pharmaceutical Company Inc., Tentative Approvoal
- Ciprofloxacin Hydrochloride Ophthalmic Solution, Akorn, Inc., Approval
- Epiduo (adapalene and benzoyl peroxide) Gel, Galderma Laboratories, L.P., Approval
- Zerit (stavudine) Capsules, Bristol-Myers Squibb Company, Labeling Revision
- Zerit (stavudine) Oral Solution, Bristol-Myers Squibb Company, Labeling Revision
- Office of Generic Drugs: November First-Time Generic Drug Approvals
- Paragraph IV Patent Certifications (updated)
December 11, 2008
- FDA requires new safety measures for oral sodium phosphate products to reduce risk of acute kidney injury
- New and Generic Drug Approvals
- Acetazolamide Extended-Release Capsules, Zydus Pharmaceuticals USA, Inc., Approval
- Acetazolamide Sodium Injection, X-Gen Pharmaceuticals, Inc., Approval
- Arimidex (anastrozole) Tablets, AstraZeneca Pharmaceutical, LP, Labeling Revision
- Augmentin XR (amoxicillin and clavulanate potassium) Extended-Release Tablets, GlaxoSmithKline, Labeling Revision
- Crixivan (indinavir sulfate) Capsules, Merck & Co., Inc., Labeling Revision
- OsmoPrep (sodium phosphate monobasic monohydrate and sodium phosphate dibasic anhydrous) Tablets, Salix Pharmaceuticals, Inc., Labeling Revision
- PCE (erythromycin) Tablets, Abbott Laboratories, Labeling Revision
- Office of Nonprescription Products: Rulemaking History for Nonprescription Products (updated)
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Date updated:
January 16, 2009
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