Established Name |
Applicant |
NDA Number |
Supp Type |
Supp Number |
Priority Review |
Receipt Date |
Approval Date |
Total Approval Time (Months) |
Indication / Description |
tadalafil |
Eli Lilly |
021368 |
SE2 |
011 |
|
12/07/06 |
01/07/08 |
13.0 |
Provides for the treatment of erectile dysfunction. |
colesevelam hydrochloride |
Daiichi Sankyo |
021176 |
SE1 |
017 |
|
12/22/06 |
01/18/08 |
12.9 |
Provides as an adjunct to diet and exercise to improve gylcemic control in adults with type 2 diabetes mellitus. |
micafungin sodium |
Astellas |
021506 |
SE1 |
008 |
|
12/22/06 |
01/22/08 |
13.0 |
Provides for the treatment of patients with candidemia, acute disseminated candidiasis, Candida peritonitis and abscesses. |
eplerenone |
Pfizer |
021437 |
SE5 |
005 |
|
08/01/07 |
01/31/08 |
6.0 |
Provides for the treatment of hypertension in pediatric patients. |
lamivudine |
GlaxoSmithKline |
020564 |
SE5 |
028 |
Y |
08/03/07 |
02/01/08 |
6.0 |
Provides for the treatment in pediatric patients for whom a solid oral dosage form is appropriate. |
mometasone furoate |
Schering |
021067 |
SE5 |
003 |
|
04/02/07 |
02/01/08 |
10.0 |
Provides for the maintenance treatment of asthma in children 4-11 years of age. |
aripiprazole |
Otsuka |
021436 |
SE5 |
021 |
Y |
08/29/07 |
02/27/08 |
6.0 |
Provides for the use for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder in pediatric patients aged 10 to 17 years. |
aripiprazole |
Otsuka |
021713 |
SE5 |
016 |
Y |
09/07/07 |
02/27/08 |
5.7 |
Provides for the use for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder in pediatric patients aged 10 to 17 years. |
aripiprazole |
Otsuka |
021729 |
SE5 |
008 |
Y |
09/07/07 |
02/27/08 |
5.7 |
Provides for the use for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder in pediatric patients aged 10 to 17 years. |
aripiprazole |
Otsuka |
021866 |
SE5 |
008 |
Y |
09/07/07 |
02/27/08 |
5.7 |
Provides for the use for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder in pediatric patients aged 10 to 17 years. |
octreotide acetate |
Novartis |
021008 |
SE1 |
021 |
|
02/28/07 |
03/03/08 |
12.1 |
Provides for the addition of new information to the package insert regarding the tumor shrinkage potential on GH-secreting pituitary adenomas. |
insulin aspart recombinant |
Novo Nordisk |
020986 |
SE5 |
047 |
|
05/14/07 |
03/14/08 |
10.0 |
Provides for pediatric pump use. |
zoledronic acid |
Novartis |
021223 |
SE5 |
016 |
Y |
09/24/07 |
03/20/08 |
5.9 |
Provides for the pharmacokinetics, efficacy and safety data in pediatric patients with severe osteogenesis imperfecta in response to FDA's Pediatric Written Request. |
divalproex sodium |
Abbott |
019680 |
SE5 |
024 |
Y |
09/24/07 |
03/24/08 |
6.0 |
Provides for use as monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures. |
divalproex sodium |
Abbott |
021168 |
SE5 |
015 |
Y |
09/24/07 |
03/24/08 |
6.0 |
Provides for use as: (1) an acute treatment of manic or mixed episodes associated with bipolar disorder, with or without psychotic features. (2) Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures. (3) Prophylaxis of migraine headaches. |
divalproex sodium |
Abbott |
022267 |
N |
000 |
Y |
09/24/07 |
03/24/08 |
6.0 |
Provides for treatment in mania associated with bipolar disorder in children and adolescents. |
atazanavir sulfate |
Bristol-Myers Squibb |
021567 |
SE5 |
015 |
Y |
09/26/07 |
03/25/08 |
6.0 |
Provides for the treatment of HIV-1 infection in pediatric patients (ages 6 to 18 years of age). |
alosetron hydrochloride |
Prometheus |
021107 |
SE2 |
013 |
|
06/01/07 |
04/01/08 |
10.0 |
Provides for the addition of items to the package insert (1) Changes to the dosing regimen for patients who become constipated while using Lotronex. (2) The addition of clinical study information for 0.5 mg once daily dosing. (3) The addition of clinical pharmacology information for the metabolism of Lotronex. (4) the addition of drug interaction information. (5) The package insert has been reformatted to meet the Physician's Labeling Rule format. |
aripiprazole |
Otsuka |
021436 |
SE1 |
020 |
|
07/11/07 |
04/06/08 |
8.9 |
Provides for the use as an adjunctive therapy added to lithium or valproate in the short-term treatment of bipolar disorder, manic or mixed, again at a starting dose of 15mg/day. |
risedronate sodium |
Procter & Gamble |
020835 |
SE2 |
030 |
|
06/22/07 |
04/22/08 |
10.0 |
Provides for the use (150 mg tablets) as a once daily dose to treat Postmenopausal Osteoporosis (PMO). |
lisdexamfetamine dimesylate |
Shire Development |
021977 |
SE5 |
001 |
|
06/29/07 |
04/23/08 |
9.8 |
Provides for the treatment of attention deficit hyperactivity disorder in the adult population. |
lubiprostone |
Sucampo |
021908 |
SE1 |
005 |
|
06/29/07 |
04/29/08 |
10.0 |
Provides for the treatment of Irritable Bowel Syndrome with constipation in women ≥ 18 years old. |
technetium Tc99m sestamibi |
Lantheus Medical Imaging |
019785 |
SE5 |
018 |
|
10/29/07 |
04/30/08 |
6.0 |
Provides for pediactric study reports submitted in response to the Agency's Written Request to qualify this product for pediactric exclusivity. |
fluticasone propionate and salmeterol xinafoate |
GlaxoSmithKline |
021077 |
SE2 |
029 |
|
10/10/06 |
04/30/08 |
18.7 |
Provides for the maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD), including chronic bronch. |
levofloxacin |
Ortho-McNeil-Janssen |
020634 |
SE5 |
047 |
|
07/05/07 |
05/05/08 |
10.0 |
Provides for inhalational anthrax (post-exposure) to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis in pediatric patients (>6 month of age and older)(Tablets). |
levofloxacin |
Ortho-McNeil-Janssen |
020635 |
SE5 |
051 |
|
07/05/07 |
05/05/08 |
10.0 |
Provides for inhalational anthrax (post-exposure) to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis in pediatric patients (>6 month of age and older)(Injection). |
levofloxacin |
Ortho-McNeil-Janssen |
021721 |
SE5 |
015 |
|
07/05/07 |
05/05/08 |
10.0 |
Provides for inhalational anthrax (post-exposure) to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis in pediatric patients (>6 month of age and older)(Oral Solution). |
aripiprazole |
Otsuka |
021436 |
SE2 |
019 |
|
07/11/07 |
05/06/08 |
9.9 |
Provides for the use as monotherapy in the acute treatment of bipolar disorder, manic or mixed, again at a starting dose of 15mg/day. |
aripiprazole |
Otsuka |
021713 |
SE1 |
015 |
|
08/29/07 |
05/06/08 |
8.3 |
Provides for the use as an adjunctive therapy added to lithium or valproate in the short-term treatment of bipolar disorder, manic or mixed, again at a starting dose of 15mg/day. |
aripiprazole |
Otsuka |
021713 |
SE2 |
014 |
|
08/29/07 |
05/06/08 |
8.3 |
Provides for the use as monotherapy in the acute treatment of bipolar disorder, manic or mixed, again at a starting dose of 15mg/day. |
aripiprazole |
Otsuka |
021729 |
SE1 |
007 |
|
08/29/07 |
05/06/08 |
8.3 |
Provides for the use as an adjunctive therapy added to lithium or valproate in the short-term treatment of bipolar disorder, manic or mixed, again at a starting dose of 15mg/day. |
aripiprazole |
Otsuka |
021729 |
SE2 |
006 |
|
08/29/07 |
05/06/08 |
8.3 |
Provides for the use as monotherapy in the acute treatment of bipolar disorder, manic or mixed, again at a starting dose of 15mg/day. |
aripiprazole |
Otsuka |
021866 |
SE1 |
007 |
|
08/29/07 |
05/06/08 |
8.3 |
Provides for the use as an adjunctive therapy added to lithium or valproate in the short-term treatment of bipolar disorder, manic or mixed, again at a starting dose of 15mg/day. |
aripiprazole |
Otsuka |
021866 |
SE2 |
006 |
|
08/29/07 |
05/06/08 |
8.3 |
Provides for the use as monotherapy in the acute treatment of bipolar disorder, manic or mixed, again at a starting dose of 15mg/day. |
atomoxetin hydrochloride |
Eli Lilly |
021411 |
SE1 |
005 |
|
03/16/04 |
05/07/08 |
49.7 |
Provides for the maintenance treatment of attention-deficit hyperactivity disorder (ADHD) in children and adolescents. |
quetiapine fumarate |
AstraZeneca |
020639 |
SE1 |
037 |
|
07/19/07 |
05/13/08 |
9.8 |
Provides for the use as maintenance treatment for bipolar I disorder, as adjunctive therapy to lithium or divalproex. |
levetiracetam |
UCB |
021872 |
SE1 |
005 |
|
07/16/07 |
05/16/08 |
10.0 |
Provides for the use as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 16 years of age and older with idiopathic generalized epilepsy. |
zoledronic acid |
Novartis |
021817 |
SE1 |
001 |
|
08/03/07 |
06/03/08 |
10.0 |
Provides for the inclusion of information under CLINICAL STUDIES on the efficacy and safety to Reclast in patients with a recent low-trauma hip fracture. |
ezetimibe |
Schering |
021445 |
SE5 |
020 |
Y |
12/17/07 |
06/05/08 |
5.6 |
Provides for the results of a pediatric study in adolescent boys and postmenarchal girls, ages 10 to 17 years of age, with heterozygous familial hyperchloesterolemia. |
doxorubicin hydrochloride liposome |
Alza |
050718 |
SE7 |
033 |
|
08/10/07 |
06/10/08 |
10.0 |
Provides for the treatment of AIDS-related Kaposi's Sarcoma after failure of prior systemic chemotherapy or intolerance to such therapy. |
somatropin |
Pfizer |
020280 |
SE1 |
060 |
|
07/02/07 |
06/12/08 |
11.4 |
Provides for the treatment of idiopathic short stature in pediatric patients whose epiphyses are not closed and for whom diagnostic evaluation excludes other causes associated with short stature that should be observed or treated by other means. |
ezetimibe/simvastatin |
Merck & Co |
021687 |
SE5 |
023 |
Y |
12/19/07 |
06/13/08 |
5.8 |
Provides the results of a pediatric study of the use in adolescent boys and postmenarchal girls, ages 10 to 17 years of age, with heterozygous familial hypecholesterolemai. |
duloxetine hydrochloride |
Eli Lilly |
022148 |
N |
000 |
|
08/14/07 |
06/13/08 |
10.0 |
Provides for the management of fibromyalgia. |
dutasteride |
GlaxoSmithKline |
021319 |
SE1 |
014 |
|
08/21/07 |
06/19/08 |
10.0 |
Provides for the use in combination with tamsulosin for the treatment of symptomatic Benign Prostatic Hyperplasia (BPH). |
lopinavir/ritonavir |
Abbott |
021251 |
SE5 |
022 |
Y |
12/21/07 |
06/20/08 |
6.0 |
Provides for the treatment of HIV-1 infection in pediatric patients 14 days to 6 months of age and from 12 to 18 years of age. |
bortezomib |
Millennium |
021602 |
SE1 |
015 |
Y |
12/20/07 |
06/20/08 |
6.0 |
Provides for the treatment of patients with multiple myeloma. |
tipranavir |
Boehringer Ingelheim |
021814 |
SE1 |
005 |
Y |
12/21/07 |
06/23/08 |
6.1 |
Provides for the treatment of HIV-1 infected pediatric (age 2 to 18 years) patients who are treatment-experienced and infected with HIV-1 strains resistant to more than one protease inhibitor. |
nevirapine |
Boehringer Ingelheim |
020636 |
SE5 |
027 |
Y |
12/20/07 |
06/24/08 |
6.1 |
Provides for the treatment of HIV-1 infection in pediatric patients 15 days and older and for patients with hepatic impairment. |
nevirapine |
Boehringer Ingelheim |
020933 |
SE5 |
017 |
Y |
12/20/07 |
06/24/08 |
6.1 |
Provides for the treatment of neonates and infants < 2 months of age, pediatric patients > 2 months of age, and for patients with hepatic impairment. |
amlodipine and valsartan |
Novartis |
021990 |
SE1 |
003 |
|
09/27/07 |
07/25/08 |
9.9 |
Provides for the initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals. |
caspofungin acetate |
Merck |
021227 |
SE5 |
021 |
Y |
01/31/08 |
07/29/08 |
5.9 |
Provides for the treatment of Empirical therapy, Candidemia (Candida infections), Esophageal Candidiasis, and for Invasive Aspergillosis. |
Proper Name |
Applicant |
BLA Number |
Supp Number |
Priority Review |
Receipt Date |
Approval Date |
Total Approval Time (Months) |
Indication/Description |
natalizumab |
Biogen Idec |
125104 |
033 |
|
12/15/06 |
01/14/08 |
13.0 |
Provides for inducing and maintaining clinical response and remission in adult patients with moderately to severely active Crohn's disease (CD) with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional CD therapies and inhibitorsof TNF-a, submitted under section 351 of the Public Health Service Act. |
adalimumab |
Abbott |
125057 |
110 |
|
03/23/07 |
01/18/08 |
9.9 |
Includes a new indication for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate, has been approved. |
herceptin |
Genentech |
103792 |
5175 |
|
12/22/06 |
01/18/08 |
12.9 |
Revise the indication for use as a single agent, for the adjuvant treatment of HER2-overexprssing node-negative (ER/PR negative or with one high-risk feature) or node-positive breast cancer, following multi-modality anthracycline based therapy has been approved. |
rituximab |
Genentech |
103705 |
5256 |
|
03/28/07 |
01/25/08 |
9.9 |
Expands the indication to include a claim to slow the progression of structural damage. |
adalimumab |
Abbott |
125057 |
114 |
|
04/26/07 |
02/21/08 |
9.9 |
Expands the indication to include the treatment of Juvenile Idiopathic Arthritis and add a 20mg pre-filled syringe. |
bevacizumab |
Genentech |
125085 |
91 |
|
05/24/06 |
02/22/08 |
21.4 |
Provides for the use in combination with paclitaxel for the treatment of patients who have not received chemotherapy for metastatic HER2 negative breast cancer. |
peginterferon alfa-2; ribavirin |
Schering |
103949 |
5123 |
|
05/10/06 |
03/26/08 |
22.6 |
Provides for interferon alfa therapy naïve, adult patients infected with chronic hepatitis C (HCV), a shorter duration of treatment for HCV patients infected with genotypes 2 and 3, and to add information regarding the risk of stroke and the 800 number for Med Watch Adverse Event Reporting to the Medication Guides. |
abatacept |
Bristol-Myers Squibb |
125118 |
045 |
|
06/08/07 |
04/07/08 |
10.0 |
Provides for a new indication for the treatment of moderate to severe polyarticular juvenile idiopathic arthritis (JIA). |
darbepoetin alfa |
Amgen |
103951 |
5111 |
|
12/19/05 |
05/05/08 |
28.5 |
Provides to expand the indication to include a new dosing regimen of 0.75 mcg/kg once every two weeks (Q2W) for denovo correction of anemia in patients with chronic renal failure who are not receiving dialysis has been approved. |
herceptin |
Genentech |
103792 |
5187 |
|
06/29/07 |
05/22/08 |
10.8 |
Provides to expand the indication as part of a treatment regimen containing doxorubicin, cyclophosphamide, and docetaxel, for the adjuvant treatment of HER2 over-expressing, node-positive or high-risk node-negative, breast cancer. |
herceptin |
Genentech |
103792 |
5189 |
|
07/05/07 |
05/22/08 |
10.6 |
Provides to expand the indication as part of a treatment regimen containing docetaxel and carboplatin, for the adjuvant treatment of HER2 over-expressing, node-positive or high-risk node-negative, breast cancer. |
vectibix |
Amgen |
125147 |
26 |
|
08/24/07 |
06/23/08 |
10.0 |
Provise torevise the clinical studies section of the package insert to include a summary of the trial design and results of study 20040249 (PACCE) |