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New Drug Application (NDA) & Biologic License Application (BLA) Efficacy Supplements Approved (CY 2008)
       

NDA Efficacy Supplements N & SE1 -SE7  SE8  BLA Efficacy Supplements

NDA Efficacy Supplements Approved (N, SE1-SE7)

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.

 

NDA Efficacy Supplements Approved (SE8)

Established Name Applicant NDA Number Supp Type Supp Number Priority Review Receipt Date Approval Date Total Approval Time (Months)
sirolimus Wyeth 021083 SE8 033   12/14/06 01/14/08 13.0
sirolimus Wyeth 021110 SE8 043   12/14/06 01/14/08 13.0
sitagliptin metformin hydrocloride Merck 022044 SE8 003   04/27/07 02/26/08 10.0
sitagliptin metformin hydrocloride Merck 022044 SE8 004   05/11/07 02/26/08 9.6
dapsone QLT USA 021794 SE8 005   05/23/07 03/14/08 9.7
albuterol sulfate GlaxoSmithKline 020983 SE8 016   09/28/07 03/26/08 5.9
argatroban Encysive 020883 SE8 014 Y 06/29/05 05/05/08 34.2
tenofovir disoproxil fumarate Gilead 021356 SE8   024   07/17/07 05/16/08 10.0
emtricitabine Gilead 021500 SE8   011   07/17/07 05/16/08 10.0
emtricitabine/tenofovir disoproxil fumarate Gilead 021752 SE8   016   07/17/07 05/16/08 10.0
emtricitabine Gilead 021896 SE8   005   07/18/07 05/16/08 10.0
oxaliplatin Sanofi-Aventis 021492 SE8   010   11/21/07 05/21/08 6.0
efavirenz/emtricitabine/tenofovir disoproxil fumarate Gilead 021937 SE8 009   07/17/07 06/06/08 10.7
methyl aminolevulinate hydrochloride Cato 021415 SE8 003   06/28/07 06/26/08 12.0
verteporfin QLT 021119 SE8 013   07/08/04 06/30/08 47.8
rosiglitazone maleate GlaxoSmithKline 021071 SE8 026   07/28/07 07/10/08 16.4
abacavir sulfate GlaxoSmithKline 020977 SE8 017   09/20/07 07/18/08 9.9
abacavir sulfate GlaxoSmithKline 020978 SE8 020   09/20/07 07/18/08 9.9
atomoxetine hydrochloride Eli Lilly 021411 SE8 024   09/27/07 07/23/08 9.9
entacavir Bristol-Myers Squibb 021797 SE8 005   09/27/07 07/25/08 9.9
entacavir Bristol-Myers Squibb 021798 SE8 006   09/27/07 07/25/08 9.9

 

BLA Efficacy Supplements Approved

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)

 

Supplement Type Description
N Type 6 NDA - New indication
SE1 New or modified indication
SE2 New dosage regimen
SE3 New route of administration
SE4 Comparative efficacy claim
SE5 Patient population altered
SE6 Change the marketing status from prescription to over-the-counter use
SE7 Complete the traditional approval of a product originally approved under subpart H (accelerated approval)
SE8 Incorporate other information based on at least one adequate and well-controlled clinical study

Updated quarterly through 07/3108

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Last Updated: August 15, 2008

 
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