Established Name |
Applicant |
NDA Number |
Supp Type |
Supp Number |
Priority Review |
Receipt Date |
Approval Date |
Total Approval Time (Months) |
Indication / Description |
drospirenone; ethinyl estradiol |
Berlex |
022045 |
N |
000 |
|
03/27/06 |
01/26/07 |
10.0 |
Provides for the use of Y AZ Tablets for the treatment of moderate acne vulgaris in women at least 14 years of age, who have no known contraindications to oral contraceptive therapy, and have achieved menarche. Y AZ should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control. |
sirolimus |
Wyeth |
021083 |
SE5 |
029 |
|
03/30/06 |
01/30/07 |
10.0 |
Provides for the addition of new dosing recommendations for use of Rapamune® (in combination with cyclosporine) for the prophylaxis of rejection in high-risk renal transplant recipients (oral solution). |
sirolimus |
Wyeth |
021110 |
SE5 |
037 |
|
03/30/06 |
01/30/07 |
10.0 |
Provides for the addition of new dosing recommendations for use of Rapamune® (in combination with cyclosporine) for the prophylaxis of rejection in high-risk renal transplant recipients (tablets). |
rosiglitazone maleate; metformin hydrochloride |
GlaxoSmithKline |
021410 |
SE1 |
016 |
|
03/31/06 |
01/31/07 |
10.0 |
Provides clinical information from one clinical study investigating the use of Avandamet® plus insulin in patients with type 2 diabetes mellitus who have not achieved adequate glycemic control with previous anti-diabetic therapies. |
sunitinib malate |
Pfizer |
021968 |
SE7 |
005 |
Y |
08/11/06 |
02/02/07 |
5.8 |
NDA 21-968 was approved under the regulations at 21 CFR 314 Subpart H for accelerated approval of new drugs for serious or life-threatening illnesses. Approval of NDA 21-968/S-005 fulfills commitments made under 21 CFR 314.510. |
fentanyl citrate |
Cephalon |
020747 |
SE5 |
027 |
Y |
09/01/06 |
02/07/07 |
5.2 |
Provides for the use of Actiq (oral transmucosal fentanyl citrate) for the management of breakthrough cancer pain in patients 16 and older with malignancies who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer
pain. |
duloxetine hydrochloride |
Lilly |
021427 |
SE1 |
011 |
|
04/27/06 |
02/23/07 |
9.9 |
Provides for the addition of a new indication for the treatment of Generalized Anxiety Disorder (GAD). |
carvedilol |
SmithKline Beecham |
020297 |
SE5 |
022 |
Y |
09/01/06 |
02/23/07 |
5.8 |
Provides for language to incorporate the results of Study 321, a multicenter, placebo-controlled, 8-month study of the effect of twice daily carvedilol in children with congestive heart failure and Study 396, a multicenter, open-label extension study to evaluate the safety of twice daily oral carvedilol in pediatric subjects with chronic heart failure in the approved package insert and reformat the package insert to conform with the Physician Labeling Rule. |
conivaptan hydrochloride |
Astellas |
022016 |
N |
000 |
|
01/30/04 |
02/28/07 |
37.0 |
Provides for the use of Vaprisol (conivaptan hydrochloride) Injection for the treatment of hypervolemic hyponatremia in hospitalized patients. |
atorvastatin calcium |
Pfizer |
020702 |
SE1 |
047 |
|
05/05/06 |
03/02/07 |
9.9 |
Provides for the addition of new indication for the use of atorvastatin in adults patients with clinically evident coronary heart disease to reduce the risk of non-fatal myocardial infection, fatal and non-fatal stroke, angina, revascularization procedures, and hospitalization for congestive heart failure. |
levetiracetam |
UCB |
021035 |
SE1 |
057 |
|
05/19/06 |
03/19/07 |
10.0 |
Provides for the use of Keppra as an adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy. (tablets) |
levetiracetam |
UCB |
021505 |
SE1 |
013 |
|
05/19/06 |
03/19/07 |
10.0 |
Provides for the use of Keppra as an adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy. (oral solution) |
entecavir |
Bristol-Myers Squibb |
021797 |
SE2 |
002 |
|
09/27/06 |
03/27/07 |
6.0 |
Provides for the use of Baraclude (entecavir) 0.5 mg and 1.0 mg Film-Coated Tablets for the treatment of chronic hepatitis B virus infection in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease. |
entecavir |
Bristol-Myers Squibb |
021798 |
SE2 |
002 |
|
09/27/06 |
03/27/07 |
6.0 |
Provides for the use of Baraclude (entecavir) 0.05 mg/mL Oral Solution for the treatment of chronic hepatitis B virus infection in adults with evidence of active viral replication and either evidence of oersistent elevations in serum aminotransferases (ALT or AST) or histologically active disease. |
zolpidem tartrate |
Sanofi Aventis |
019908 |
SE5 |
022 |
Y |
09/29/06 |
03/28/07 |
5.9 |
Provides for the short-term treatment of insomnia characterized by difficulties with sleep initiation. |
olanzapine;fluoxetine hydrochloride |
Eli Lilly |
021520 |
SE2 |
010 |
|
06/23/06 |
04/9/07 |
9.5 |
Provides for the addition of a 3 mg/25 mg dosage strength, with appropriate modifications to the DESCRIPTION, DOSAGE, AND ADMINISTRATION, and HOW SUPPLIED sections of labeling. |
risperidone |
Janssen |
021346 |
SE2 |
015 |
|
06/19/06 |
04/12/07 |
9.8 |
Provides for an additional dosage strength (12.5 mg) for Injection. |
insulin glulisine |
Sanofi-Aventis |
021629 |
SE3 |
010 |
|
06/12/06 |
04/12/07 |
10.0 |
Provides for intravenous administration in a controlled clinical setting for the control of hyperglycemia. |
montelukast sodium |
Merck |
020829 |
SE1 |
036 |
|
02/18/05 |
04/13/07 |
25.8 |
Provides for the prevention of exercise-induced bronchoconstriction in patients 15 years of age and older. (Tablets) |
montelukast sodium |
Merck |
020830 |
SE1 |
038 |
|
02/18/05 |
04/13/07 |
25.8 |
Provides for the prevention of exercise-induced bronchoconstriction in patients 15 years of age and older. (Chewable Tablets) |
montelukast sodium |
Merck |
021409 |
SE1 |
016 |
|
02/18/05 |
04/13/07 |
25.8 |
Provides for the prevention of exercise-induced bronchoconstriction in patients 15 years of age and older. (Oral Granules) |
risedronate sodium |
Proctor & Gamble |
020835 |
SE2 |
025 |
|
06/16/06 |
04/16/07 |
10.0 |
Provides for the use of 75 mg two consecutive days per month for the prevention and treatment of postmenopausal osteoporosis. |
cytarabine liposome |
SkyePharma |
021041 |
SE7 |
018 |
|
06/22/06 |
04/19/07 |
9.9 |
Provides for the inclusion of information regarding completed study SKY0101-010 in the labeling. |
synthetic conjugated estrogen |
Duramed |
021443 |
SE1 |
004 |
|
06/23/06 |
04/23/07 |
10.0 |
Provides for the treatment of moderate to severe vaginal dryness and pain with intercourse, symptoms of vulvar and vaginal atrophy, associated with menopause. |
alendronate sodium/vitamin D3 |
Merck |
021762 |
SE2 |
004 |
|
06/26/06 |
04/26/07 |
10.0 |
Provides for a combination tablet of 70 mg alendronate (equivalent to 91.37 mg alendronate sodium) and 5600 IU of vitamin D3 for the treatment of osteoporosis in postmenopausal women and the treatment to increase bone mass in men with osteoporosis. |
paliperidone |
Janssen |
022043 |
N |
000 |
|
06/27/06 |
04/27/07 |
10.0 |
Provides for the maintenance treatment of schizophrenia. |
dalteparin sodium |
Pharmacia & Upjohn |
020287 |
SE1 |
035 |
|
03/17/04 |
05/1/07 |
37.5 |
Provides for the extended treatment of symptomatic venous thromboembolism (VTE) [proximal deep vein thrombosis (DVT) and/or pulmonary embolism (PE)] to reduce the recurrence of VTE in patients with cancer. |
gemifloxacin mesylate |
Oscient |
021158 |
SE2 |
007 |
|
11/21/05 |
05/1/07 |
17.3 |
Provides for the treatment of selected susceptible strains of Streptococcus pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae, and Chlamydia pneumoniae for community-acquired pneumonia. |
enoxaparin sodium |
Sanofi-Aventis US |
022138 |
N |
000 |
Y |
11/17/06 |
05/16/07 |
5.9 |
Provides for the treatment of acute ST-segment elevation myocardial infarction (STEMI). |
doxorubicin hydrochloride |
ALZA |
050718 |
SE1 |
029 |
Y |
11/22/06 |
05/17/07 |
5.8 |
Provides for, in combination with bortezomib, the treatment of patients with multiple myeloma who have not previously received bortezomib and have received at least one prior therapy. |
tinidazole |
Mission |
021618 |
SE1 |
003 |
|
07/21/06 |
05/21/07 |
10.0 |
Provides for the treatment of bacterial vaginosis in non-pregnant females. |
somatropin |
Novo Nordisk |
021148 |
SE1 |
016 |
|
07/18/06 |
05/31/07 |
10.4 |
Provides for the treatment of short stature in children with Noonan syndrome. |
betaxolol hydrochloride |
Alcon |
019845 |
SE5 |
020 |
Y |
12/18/06 |
06/08/07 |
5.7 |
Provides for the treatment of elevated intraocular pressure in patients with chronic open-angle glaucoma or ocular hypertension. |
timolol maleate |
Falcon |
020963 |
SE5 |
010 |
Y |
12/18/06 |
06/08/07 |
5.7 |
Provides for the treatment of elevated intraocular pressure in patients with chronic open-angle glaucoma or ocular hypertension. |
omega-3 acid ethylesters |
Reliant |
021853 |
N |
000 |
|
01/12/04 |
06/12/07 |
41.0 |
Provides for the treatment as an add-on to HMG-CoA reductase inhibitor therapy in patients with persistent high triglycerides despite HMG-CoA reductase inhibitor therapy. |
pregabalin |
C.P. Pharms |
021446 |
SE1 |
010 |
Y |
12/21/06 |
06/21/07 |
6.0 |
Provides for the management of fibromyalgia. |
somatropin |
EMD Serono |
020604 |
SE1 |
040 |
|
06/14/06 |
07/13/07 |
13.0 |
Provides for the revision of the CLINICAL PHARMACOLOGY, CLINICAL STUDIES, PRECAUTIONS, and ADVERSE REACTIONS sections of the package insert to include information regarding use in patients with HIV-associated adipose redistribution syndrome (HARS). |
metoprolol succinate |
AstraZeneca |
019962 |
SE5 |
033 |
Y |
05/15/06 |
07/18/07 |
14.1 |
Provides for the CLINICAL PHARMACOLOGY, Pharmacokinetics, Pediatrics, PRECAUTIONS, Pediatric Use, DOSAGE AND ADMINISTRATION, Hypertension, Pediatric Hypertension patients ≥6 years of age. |
zoledronic acid |
Novartis |
022080 |
N |
000 |
|
10/17/06 |
08/17/07 |
10.0 |
Provides for the treatment of osteoporosis in postmenopausal women. |
risperidone |
Johnson & Johnson |
020272 |
SE5 |
046 |
Y |
12/21/06 |
08/22/07 |
8.0 |
Provides for the use of oral risperidone HCL for the treatment of schizophrenia in adolescents (ages 13-17). |
risperidone |
Johnson & Johnson |
020272 |
SE5 |
047 |
Y |
12/21/06 |
08/22/07 |
8.0 |
Provides for the use of oral risperidone HCL for the treatment of bipolar I disorder in children (ages 10-12) and adolescents (ages 13-17). |
risperidone |
Johnson & Johnson |
020588 |
SE5 |
036 |
Y |
12/21/06 |
08/22/07 |
8.0 |
Provides for the use of oral risperidone HCL for the treatment of schizophrenia in adolescents (ages 13-17). |
risperidone |
Johnson & Johnson |
020588 |
SE5 |
037 |
Y |
12/21/06 |
08/22/07 |
8.0 |
Provides for the use of oral risperidone HCL for the treatment of bipolar I disorder in children (ages 10-12) and adolescents (ages 13-17). |
risperidone |
Johnson & Johnson |
021444 |
SE5 |
020 |
Y |
12/21/06 |
08/22/07 |
8.0 |
Provides for the use of oral risperidone HCL for the treatment of schizophrenia in adolescents (ages 13-17). |
risperidone |
Johnson & Johnson |
021444 |
SE5 |
021 |
Y |
12/21/06 |
08/22/07 |
8.0 |
Provides for the use of oral risperidone HCL for the treatment of bipolar I disorder in children (ages 10-12) and adolescents (ages 13-17). |
palonosetron hydrochloride |
Helsinn Healthcare |
021372 |
SE2 |
006 |
|
08/02/06 |
08/30/07 |
12.9 |
Provides for a change in the dosage and administration section of the Aloxi labeling. |
levofloxacin |
Ortho-McNeil |
020635 |
SE5 |
046 |
Y |
12/21/06 |
09/11/07 |
8.7 |
Provides for the addition of pediatric safety information to the Levaquin package insert. (Injection) |
levofloxacin |
Ortho-McNeil |
021721 |
SE5 |
011 |
Y |
12/21/06 |
09/11/07 |
8.7 |
Provides for the addition of pediatric safety information to the Levaquin package insert. (Oral Solution) |
levofloxacin |
Ortho-McNeil |
020634 |
SE5 |
043 |
Y |
12/21/06 |
09/11/07 |
8.7 |
Provides for the addition of pediatric safety information to the Levaquin package insert. (Tablets) |
levetiracetam |
UCB |
021872 |
SE1 |
003 |
|
11/15/06 |
09/12/07 |
9.9 |
Provides for use as adjunctive therapy in the treatment of myoclonic seizures in adults ith juvenile myoclonic epilepsy |
carisoprodol |
MedPointe |
011792 |
SE2 |
041 |
|
11/13/06 |
09/13/07 |
10.0 |
Provides for the relief of discomfort associated with acute, painful musculoskeletal conditions. |
raloxifene hydrochloride |
Eli Lilly |
022042 |
N |
000 |
|
11/14/06 |
09/13/07 |
10.0 |
Provides for reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis and reduction in risk of invasive breast cancer in postmenopausal women at high risk for invasive breast cancer. |
levofloxacin |
Ortho-McNeil |
020634 |
SE2 |
041 |
|
11/16/06 |
09/14/07 |
9.9 |
Provides for the treatment of complicated urinary tract infection and acute pyelonephritis with Levaquin 750 mg once daily for five days. (Tablets) |
levofloxacin |
Ortho-McNeil |
020635 |
SE2 |
044 |
|
11/16/06 |
09/14/07 |
9.9 |
Provides for the treatment of complicated urinary tract infection and acute pyelonephritis with Levaquin 750 mg once daily for five days. (Injection) |
levofloxacin |
Ortho-McNeil |
021721 |
SE2 |
009 |
|
11/16/06 |
09/14/07 |
9.9 |
Provides for the treatment of complicated urinary tract infection and acute pyelonephritis with Levaquin 750 mg once daily for five days. (Oral Solution) |
somatropin |
Novo Nordisk |
021148 |
SE1 |
017 |
|
10/23/06 |
09/20/07 |
10.9 |
Provides for the treatment of short stature in children with Turner's syndrome. |
sodium chloride; sodium bicarbonate; potassium chloride; bisacodyl |
Braintree Lab |
021551 |
SE2 |
006 |
|
08/29/06 |
09/24/07 |
12.9 |
Provides for reduction of the bisacodyl dosage from 20 mg to 10 mg. |
docetaxel |
Sanofi-Aventis |
020449 |
SE1 |
045 |
Y |
03/29/07 |
09/28/07 |
6.0 |
Provides in combination with cisplatin and fluorouracil for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN). |
tipranavir |
Boehringer Ingelheim |
021814 |
SE7 |
003 |
|
12/04/06 |
10/04/07 |
10.0 |
Provides for combination antiretroviral treatment of HIV-1 infected adult patients who are treatment-experienced and infected with HIV-1 strains resistant to more than one protease inhibitor. |
fosamprenavir calcium |
GlaxoSmithKline |
021548 |
SE2 |
013 |
|
12/14/06 |
10/12/07 |
9.9 |
Provides for the treatment of HIV infection in therapy-naïve adults. |
aripiprazole |
Otsuka |
021436 |
SE5 |
017 |
Y |
03/26/07 |
10/29/07 |
7.1 |
Provides for the treatment of schizophrenia in adolescents aged 13-17 (Tablets). |
aripiprazole |
Otsuka |
021713 |
SE5 |
012 |
|
08/28/07 |
10/29/07 |
2.0 |
Provides for the treatment of schizophrenia in adolescents aged 13-17 (Dismelt Tablets). |
aripiprazole |
Otsuka |
021729 |
SE5 |
004 |
|
08/28/07 |
10/29/07 |
2.0 |
Provides for the treatment of schizophrenia in adolescents aged 13-17 (Oral Solution). |
aripiprazole |
Otsuka |
021866 |
SE5 |
004 |
|
08/28/07 |
10/29/07 |
2.0 |
Provides for the treatment of schizophrenia in adolescents aged 13-17 (Intramuscular Use Only). |
rosuvastatin calcium |
AstraZeneca |
021366 |
SE1 |
010 |
|
01/08/07 |
11/08/07 |
10.0 |
Provides for a new indication for Crestor as adjunctive therapy to diet to slow the progression of atherosclerosis in adult as part of a treatment strategy to lower Total-C and LDL-C to target levels. |
dasatinib |
Bristol-Myers Squibb |
021986 |
SE2 |
001 |
Y |
05/11/07 |
11/08/07 |
6.0 |
Provides for the use of a lower dose for the treatment of adults with chronic phase chronic myeloid leukemia (CML) with resistance or intolerance to prior therapy including imatinib mesylate and provide information on the results of a Phase 2 randomized trial of Sprtcel 70 mg twice daily or imatinib 800 mg daily. |
certirizine hydrochloride;pseudoeohedrine hydrochloride |
Pfizer |
021150 |
SE6 |
007 |
|
01/11/07 |
11/09/07 |
9.9 |
Provides for the temporary relief of symptoms of hay fever or other upper respiratory allergies: runny nose, sneezing, itchy, watery eyes, itching of the nose or throat, and nasal congestion in adults and children 12 years of age and older. |
lopinavir;ritonavir |
Abbott |
021251 |
SE2 |
018 |
Y |
05/11/07 |
11/09/07 |
6.0 |
Provides for the use of a lower strength, to be used for twice daily dosing in pediatric patients weighing greater than 15kg. |
lopinavir;ritonavir |
Abbott |
021906 |
SE2 |
007 |
Y |
05/10/07 |
11/09/07 |
6.0 |
Provides for the use of a lower strength, to be used for twice daily dosing in pediatric patients weighing greater than 15kg. |
quetiapine fumarate |
AstraZeneca |
022172 |
N |
000 |
|
01/22/07 |
11/15/07 |
9.8 |
Provides treatment of schizophrenia. |
certirizine hydrochloride |
Pfizer |
019835 |
SE6 |
022 |
|
01/16/07 |
11/16/07 |
10.0 |
Provides for the temporary relief of symptoms of hay fever or other upper respiratory allergies: runny nose, sneezing, itchy, watery eyes, itching of the nose or throat in adults and children 6 years of age and older, and for nonprescription use of Zyrtec Hives Relief tablets for the relief of itching due to hives (urticaria) in adults and children 6 years of age and older. |
irbesartan/hydrochlorothiazide |
Sanofi-Aventis |
020758 |
SE1 |
037 |
|
12/16/05 |
11/16/07 |
23.0 |
Provides treatment as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals. |
aripiprazole |
Otsuka |
021436 |
SE1 |
018 |
Y |
05/16/07 |
11/16/07 |
6.0 |
Provides for the use as an adjunctive treatment to treat patients with major depressive disorder. (Oral Tablets) |
certirizine hydrochloride |
Pfizer |
021621 |
SE6 |
005 |
|
01/16/07 |
11/16/07 |
10.0 |
Provides for the temporary relief of symptoms of hay fever or other upper respiratory allergies: runny nose, sneezing, itchy, watery eyes, itching of the nose or throat in adults and children 6 years of age and older, and for nonprescription use of Children's Zyrtec Hives Relief chewable tablets for the relief of itching due to hives (urticaria) in adults and children 6 years of age and older. |
aripiprazole |
Otsuka |
021713 |
SE1 |
013 |
|
08/29/07 |
11/16/07 |
2.6 |
Provides for the use as an adjunctive treatment to treat patients with major depressive disorder. (Oral Solution) |
aripiprazole |
Otsuka |
021729 |
SE1 |
005 |
|
08/29/07 |
11/16/07 |
2.6 |
Provides for the use as an adjunctive treatment to treat patients with major depressive disorder. (Orally Disintegrating Tablets) |
sorafenib |
Bayer |
021923 |
SE1 |
007 |
Y |
06/20/07 |
11/16/07 |
4.9 |
Provides for the treatment of unresectable hepatocellular carcinoma. |
ciclesonide |
Nycomed |
022124 |
N |
000 |
|
12/22/05 |
11/21/07 |
23.0 |
Provides for the treatment of seasonal allergic rhinitis in patients 6 through less than 12 years of age. |
duloxetine hydrochloride |
Eli Lilly |
021427 |
SE1 |
015 |
|
11/01/06 |
11/28/07 |
12.9 |
Provides revisions to the Precautions-Discontinuation of Treatment with Cymbalta and Adverse Reactions-Postmarketing Spontaneous Reports sections. |
valsartan |
Novartis |
021283 |
SE5 |
024 |
Y |
05/29/07 |
11/29/07 |
6.0 |
Provides for the treatment of hypertension in pediatric patients 6-16 years of age. |
triamcinolone acetonide |
Alcon |
022223 |
N |
000 |
|
05/29/07 |
11/29/07 |
6.0 |
Provides for the treatment of the following ophthalmic diseases: sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteriods. Also, is indicated for visualization during vitrectomy. |
fluocinolone acetonide |
Hill Dermaceuticals |
019452 |
SE5 |
024 |
|
02/15/07 |
12/12/07 |
9.9 |
Provides for the treatment of atopic dermatitis in pediatric patients 3 months to 2 years old. |
venlafaxine hydrochloride |
Wyeth |
020699 |
SE1 |
047 |
|
11/03/03 |
12/14/07 |
49.4 |
Provides for the long-term treatment of Social Anxiety Disorder. |
thyrotropin alfa |
Genzyme |
020898 |
SE1 |
029 |
Y |
11/01/04 |
12/14/07 |
37.4 |
Provides as an adjunctive treatment for radioiodine ablation of thyroid tissue remnants in patients who have undergone thyroidectomy for well-differentiated thyroid cancer and who do not have evidence of metastatic thyroid cancer. |
famotidine |
Merck & Co |
020801 |
SE2 |
012 |
|
03/23/07 |
12/17/07 |
8.8 |
Provides for a new 20 mg strength formulation with three different flavors and new labels for Pepcid AC chewable tablet for the nonprescription treatment of frequent heartburn. |
adefovir dipivoxil |
Gilead |
021449 |
SE5 |
011 |
|
06/25/07 |
12/19/07 |
5.8 |
Provides for the treatment of chronic hepatitis B in pediatric patients (ages 12 to 17 years). |
zolpidem tartrate |
Sanofi Aventis |
021774 |
SE1 |
003 |
|
02/20/07 |
12/20/07 |
10.0 |
Provides for increase duration of use (6 months) of Ambien CR 12.5 mg (adults) and 6.25 mg (elderly). |