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New Drug Application (NDA) & Biologic License Application (BLA) Efficacy Supplements Approved (CY 2006)

 

            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
sunitinib Pfizer 021968 N 000 Y 8/11/2005 1/26/2006 5.5 Provides for the treatment of advanced renal cell carcinoma.
bromfenac sodium ISTA 021664 SE1 001   7/18/2005 1/27/2006 6.3 Provides for the use of Xibrom (bromfenac ophthalmic solution) 0.09% for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract extraction.
sumatriptan succinate GlaxoSmithKline 020080 SE2 036   4/8/2005 2/1/2006 9.8 Provides for the use of Imitrex (sumatriptan) STATdose 4mg
for the acute treatment of migraine headache.
albuterol sulfate Ivax 021457 SE1 003   4/12/2005 2/3/2006 9.8 Provides for the use of ProAir HFA (albuterol sulfate) Inhalation Aerosol for the prevention of exercise-induced bronchospasm in adolescents and adults 12 years of age and older.
azelastine hydrochloride Medpointe 020114 SE2 014   4/18/2005 2/17/2006 10.0 Provides for a new dosing regimen of one spray twice daily in Seasonal Allergic Rhinitis patients 12 years of age and older.
anidulafungin Vicuron 021948 N 000 Y 8/18/2005 2/17/2006 6.0 Provides for the use of Eraxis (anidulafungin) for Injection for the treatment of patients with candidemia and other forms of Candida infections (intra-abdominal abscess and peritonitis)
selegiline Somerset 021708 N 000   10/16/2003 2/27/2006 28.4 Provides for the use of EMSAM (selegiline transdermal system) patches,
6mg/24 hours, 9mg/24 hours, and 12mg/24 hours in the longer-term treatment of major depressive disorder in adult patients.
fluticasone propionate GlaxoSmithKline 021433 SE5 004   4/29/2005 2/28/2006 10.0 Provides for the use Flovent HFA Inhalation Aerosol for the maintenance treatment of asthma as prophylactic therapy in patients 4 through 11 years of age.
fluocinonide Medicis 021758 SE1 001   5/2/2005 3/2/2006 10.0 Provides for the use of Vanos™ (fluocinonide) Cream, 0.1%,
as a corticosteroid indicated for relief of the inflammatory and pruritic manifestations of corticosteroid
responsive dermatoses in patients 12 years of age or older.
emtricitabine; tenofovir disoproxil fumarate Gilead Sciences 021752 SE7 005   5/9/2005 3/8/2006 10.0 Provides for the use of TRUVADA (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) Tablets for use in combination with other antiretroviral agents (such as non-nucleoside reverse transcriptase inhibitors or protease inhibitors) for the treatment of HIV-1 infection in adults.
tenofovir disoproxil fumarate Gilead Sciences 021356 SE7 016   5/9/2005 3/8//2006 10.0 Provides for the use of VIREAD (tenofovir disoproxil fumarate) 300 mg Capsules in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults.
ibuprofen Banner 021472 SE1 005   1/27/2005 3/13/2006 13.5 Provides for ibuprofen capsules, 200 mg, for the treatment of migraine.
simvastatin; ezetimibe MSP Singapore 021687 SE4 006   5/17/2005 3/16/2006 10.0 Provides for changes to the CLINICAL STUDIES, Primary Hypercholesterolemia,
Vytorin subsection of the package insert to add efficacy data for the ezetimibe/simvastatin combination
product and for an atorvastatin product on LDL-C and other lipid parameters in patients with hypercholesterolemia.
treprostinil sodium United Therapeutics 021272 SE7 005 Y 10/13/2005 3/20/2006 5.2 Provides information to the labeling on the use of Remodulin Injection (treprostinil sodium) 1.0, 2.5, 5.0, and 10 mg/ml for the treatment of patients with pulmonary arterial hypertension (PAH) requiring transition from Flolan®.
docetaxel Sanofi-Aventis 020449 SE1 035 Y 9/26/2005 3/22/2006 5.8 Provides for the use of Taxotere® (docetaxel) Injection Concentrate in combination with cisplatin and fluorouracil for the treatment of patients with advanced gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not
received prior chemotherapy for advanced disease.
zanamivir GlaxoSmithKline 021036 SE1 008 Y 11/4/2005 3/29/2006 4.8 Provides for the use of RELENZA® (zanamivir for inhalation) for prophylaxis of influenza in adults and children five years of age and older.
zanamivir GlaxoSmithKline 021036 SE1 009 Y 11/4/2005 3/29/2006 4.8 Provides for the use of RELENZA® (zanamivir for inhalation) for prophylaxis of influenza in adults and children five years of age and older.
tacrolimus Astellas 050708 SE1 024   6/2/2005 3/29/2006 9.9 Provides for the use of Prograf® (tacrolimus) Capsules for the prophylaxis of organ rejection in patients receiving allogeneic heart transplants.
tacrolimus Astellas 050709 SE1 019   6/2/2005 3/29/2006 9.9 Provides for the use of Prograf® (tacrolimus) Injection for the prophylaxis of organ rejection in patients receiving allogeneic heart transplants.
fluvastatin sodium Novartis 020261 SE5 036 Y 10/17/2005 4/10/2006 5.8 Provides for the addition of an indication for the treatment of heterozygous familial hypercholesterolemia in adolescent boys and postmenarchal girls, ages 10 to 16 years, with a recommended dosing range of Lescol capsules 20 to 40 mg twice daily.
fluvastatin sodium Novartis 020261 SE2 035   6/16/2005 4/10/2006 9.8 Provides for the addition of an indication for the treatment of heterozygous familial hypercholesterolemia in adolescent boys and postmenarchal girls, ages 10 to 16 years, with a recommended dosing range of Lescol capsules 20 to 40 mg twice daily.
fluvastatin sodium Novartis 021192 SE5 011 Y 10/17/2005 4/10/2006 5.8 Provide for the addition of an indication for the treatment of heterozygous familial hypercholesterolemia in adolescent boys and postmenarchal girls, ages 10 to 16 years, with a recommended dosing range of Lescol XL 80 mg tablet once daily.
fluvastatin sodium Novartis 021192 SE2 010   6/16/2005 4/10/2006 9.8 Provide for the addition of an indication for the treatment of heterozygous familial hypercholesterolemia in adolescent boys and postmenarchal girls, ages 10 to 16 years, with a recommended dosing range of Lescol XL 80 mg tablet once daily.
amlodipine besylate; benazepril hydrochloride Novartis 020364 SE2 023   12/23/2002 4/11/2006 39.6 Provides for two higher strengths, 5/40 and 10/40 mg, of Lotrel (amlodipine besylate and benazepril HCL) Capsules for the treatment of hypertension.
somatropin (rDNA origin) Pfizer 020280 SE1 049   6/28/2005 4/27/2006 10.0 Provides for the use of Genotropin® (somatropin [rDNA origin] for injection) as long-term treatment of growth failure associated with Turner Syndrome in patients who have open epiphyses.
esomeprazole magnesium AstraZeneca 021153 SE5 022 Y 10/28/2005 4/28/2006 6.0 Provides for the use of the revision of the Pediatric section of the package insert to add information regarding the use of Nexium® Delayed-Release Capsules in adolescent patients, 12-17 years of age, inclusive, for the short term treatment of gastroesophageal reflux disease (GERD).
valsartan; hydrochlorothiazide Novartis 020818 SE2 027   6/30/2005 4/28/2006 9.9 Provides for the addition of two new dose strengths (320/12.5 and 320/25 mg) of Diovan HCT (valsartan hydrochlorothiazide) Tablets for the treatment of hypertension.
octreotide actetate Novartis 021008 SE5 018 Y 11/10/2005 5/10/2006 6.0 Provides the results of a study of the use of Sandostatin LAR Depot in
pediatric patients with hypothalamic obesity.
rosiglitazone maleate; metformin hydrochloride SB Pharmco 021410 SE1 010   7/1/2005 5/19/2006 10.6 Provides clinical data in support of Avandamet® (rosiglitazone maleate and metformin HCl) as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus when treatment with dual rosiglitazone
and metformin therapy is appropriate.
ezetimibe MSP Singapore 021445 SE1 013   7/27/2005 5/23/2006 9.9 Provides for a new indication for Zetia to be administered in combination with fenofibrate, as adjunctive therapy to diet for the reduction of elevated total-C, LDL-C, Apo B, and non-HDL-C in patients with mixed hyperlipidemia.
thalidomide Celgene 021430 N 000   12/23/2003 5/25/2006 29.1 Provides for the use of Thalomid® (thalidomide) capsules, 50 mg, 100
mg, and 200 mg for the treatment of patients with newly diagnosed multiple myeloma.
daptomycin Cubist 021572 SE1 008 Y 9/26/2005 5/25/2006 7.9 Provides for the use of CUBICIN® (daptomycin for injection) Intravenous, 500 mg/vial, for the treatment of Staphylococcus aureus bloodstream infections (bacteremia), including those with right-sided infective endocarditis, caused by methicillin-susceptible
and methicillin-resistant isolates.
bupropion hydrochloride extended-release GlaxoSmithKline 021515 SE1 010 Y 11/24/2004 6/12/2006 18.6 Provides for the use of Wellbutrin XL in the prevention of seasonal major depressive episodes in patients with
seasonal affective disorder.
topotecan hydrochloride GlaxoSmithKline 020671 SE1 014 Y 12/15/2005 6/14/2006 6.0 Provides for the use of HYCAMTIN® (topotecan hydrochloride) for Injection 4 mg in combination with cisplatin for the treatment of Stage IV-B, recurrent, or persistent carcinoma of the cervix which is not amenable to curative treatment with surgery and/or radiation therapy.
bimatoprost Allergan 021275 SE1 013   7/2/2003 6/22/2006 35.7 Provides for the use of Lumigan (bimatoprost ophthalmic solution) 0.03% for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension.
rivastigmine tartrate Novartis 021025 SE1 008   2/13/2006 6/27/2006 4.4 Provides for the use of Exelon oral solution in the treatment of mild to moderate dementia associated with Parkinson’s Disease.
rivastigmine tartrate Novartis 020823 SE1 016   9/1/2005 6/27/2006 9.8 Provides for the use of Exelon capsules in the treatment of mild to moderate dementia associated with Parkinson’s Disease.
dasatinib Bristol-Myers Squibb 022072 N 000 Y 12/28/2005 6/28/2006 6.0 Provides for the use of SPRYCEL (dasatinib) Tablets for the treatment of
adults with Philadelphia chromosome-positive acute lymphoblastic leukemia with resistance or intolerance to prior therapy.
lenalidomide Celgene 021880 SE1 001 Y 12/30/2005 6/29/2006 6.0 Provides for the use of Revlimid® 15 mg and 25 mg capsules in combination with dexamethasone for the treatment of multiple myeloma patients who have received at least one prior therapy.
aprepitant Merck 021549 SE1 010   8/30/2005 6/30/2006 10.0 Provides for the use of Emend™ (aprepitant) Capsules for the
prevention of post-operative nausea and vomiting (PONV) utilizing a new 40 mg strength.
gemcitabine hydrochloride Lilly 020509 SE1 039   6/17/2005 7/14/2006 12.9 Provides for the use of Gemzar in combination with carboplatin for the treatment of patients with advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy.
famciclovir Novartis 020363 SE2 027   10/17/2005 7/28/2006 9.3 Provides for the use of Famvir® (famciclovir) tablets in a new dosing recommendation for the treatment of recurrent genital herpes in immunocompetent patients, specifically a reduction in course of therapy from famciclovir 125 mg bid for 5 days to 1000 mg bid for 1 day.
famciclovir Novartis 020363 SE1 028   11/14/2005 7/28/2006 8.4 Provides for the use of Famvir® (famciclovir) tablets for the treatment of recurrent herpes labialis (cold sores) in immunocompetant patients with a single dose of famciclovir 1500 mg.
ertapenem sodium Merck 021337 SE1 021   11/10/2005 8/10/2006 9.0 Provides for the use of INVANZ® (Ertapenem Sodium) for the
prophylaxis of surgical site infection following elective colorectal surgery.
risedronate Proctor and Gamble 020835 SE1 022   10/20/2005 8/11/2006 9.7 Provides for the use of Actonel 35 mg once a week for the treatment of osteoporosis in men.
levetiracetam UCB 021505 SE1 009   10/18/2005 8/15/2006 9.9 Provides for the use of Keppra (levetiracetam) oral solution for adjunctive therapy of myoclonic seizures in adults and adolescents age 12 and over with juvenile myoclonic epilepsy.
levetiracetam UCB 021035 SE1 050   10/18/2005 8/15/2006 9.9 Provides for the use of Keppra (levetiracetam) tablets for adjunctive
therapy of myoclonic seizures in adults and adolescents age 12 and over with juvenile myoclonic epilepsy.
clopidogrel bisulfate Sanofi-Aventis 020839 SE1 034 Y 11/17/2005 8/17/2006 9.0 Provides for the use of Plavix (clopidogrel bisulfate) 75 mg tablets for patients with ST-segment elevation acute myocardial infarction.
levonorgestrel Duramed 021045 SE6 011   7/22/2004 8/24/2006 40.1 Provides for Over-the-Counter availability of Plan B® for consumers 18 years and older. Plan B® remains available by prescription only for women 17 years and younger.
augmented betamethasone dipropionate Schering 018741 SE5 028   10/31/2005 8/28/2006 9.9 Provides for a Geriatric Use section for Diprolene® (augmented betamethasone dipropionate) Ointment 0.05%.
augmented betamethasone dipropionate Schering 019555 SE5 026   10/28/2005 8/28/2006 10.0 Provides for a Geriatric Use section for Diprolene® (augmented betamethasone dipropionate) AF Cream, 0.05%.
augmented betamethasone dipropionate Schering 019716 SE5 022   10/28/2005 8/28/2006 10.0 Provides for a Geriatric Use section for Diprolene® (augmented betamethasone dipropionate) Lotion, 0.05% .
lamotrigine GlaxoSmithKline 020241 SE1 027   2/7/2005 9/22/2006 19.5 Provides for Lamictal tablets for adjunctive treatment of primary generalized tonic-clonic seizures in adults and pediatric patients.
lamotrigine GlaxoSmithKline 020764 SE1 020   2/7/2005 9/22/2006 19.5 Provides for Lamictal Chewable Dispersable tablets for adjunctive treatment of primary generalized tonic-clonic seizures in adults and pediatric patients.
imatinib mesylate Novartis 021588 SE1 016 Y 3/28/2006 9/27/2006 6.0 Provides for the use of Gleevec for newly diagnosed Philadelphia chromosome positive CML in pediatric patients.
ezetimibe; simvastatin Merck 021687 SE4 011   12/5/2005 10/3/2006 9.9 Provides for labeling changes to add efficacy data for ezetimibe; simvastatin product and for a rosuvastatin product on LDL-C and other lipid parameters in patients with hypercholesterolemia.
drospirenone; ethinyl estradiol Berlex 021873 N 000   12/23/2004 10/4/2006 21.4 Provides for YAZ (drospirenone/ethinyl estradiol) for Oral Contraception and Premenstrual Dysphoric Disorder.
risperidone Janssen 020272 SE1 036 Y 12/19/2003 10/6/2006 33.6 Provides for the use of Risperdal Tablets in treatment of the irritability associated with autistic disorder.
risperidone Janssen 020588 SE1 024 Y 12/19/2003 10/6/2006 33.6 Provides for the use of Risperdal Oral Solution in treatment of the irritability associated with autistic disorder.
risperidone Janssen 021444 SE1 008 Y 12/19/2003 10/6/2006 33.6 Provides for the use of Risperdal M-Tabs in treatment of the irritability associated with autistic disorder.
esomeprazole AstraZeneca 021153 SE1 023   12/15/2005 10/11/2006 9.9 Provides for the use of NEXIUM®
(esomeprazole magnesium) Delayed-Release Capsules for the treatment of pathological hypersecretory
conditions including Zollinger-Ellison Syndrome.
doneprezil hydrochloride Eisai 020690 SE1 026   12/16/2005 10/13/2006 9.9 Provides for the use of Aricept Tablets in the treatment of dementia of the Alzheimer’s type in patients with severe Alzheimer’s Disease.
doneprezil hydrochloride Eisai 021719 SE1 001   9/26/2006 10/13/2006 0.6 Provides for the use of Aricept Oral Solution in the treatment of dementia of
the Alzheimer’s type in patients with severe Alzheimer’s Disease.
doneprezil hydrochloride Eisai 021720 SE1 003   9/26/2006 10/13/2006 0.6 provide for the use of Aricept Orally Disintegrating Tablets in the treatment of dementia of the Alzheimer’s type in patients with severe Alzheimer’s Disease.
docetaxel Sanofi-Aventis 020449 SE1 039 Y 4/17/2006 10/17/2006 6.0 Provides for the use of Taxotere (docetaxel) Injection Concentrate in combination with cisplatin and fluorouracil for the induction treatment of patients with inoperable locally advanced squamous cell carcinoma of the head and neck (SCCHN).
ketotifen fumarate Novartis 021066 SE6 011   12/19/2005 10/19/2006 10.0 Provides for the switch of Zaditor™ (ketotifen fumarate ophthalmic solution) from prescription only to the to over-the-counter indication of the temporary
relief of itchy eyes due to pollen, ragweed, grass, animal hair, and dander.
imatinib mesylate Novartis 021588 SE1 011   12/19/2005 10/19/2006 10.0 Provides for the treatment of adult dermafibrosarcoma protuberans (DFSP).
imatinib mesylate Novartis 021588 SE1 012   12/19/2005 10/19/2006 10.0 Provides for the treatment of adult myelodysplastic syndrome/myeloproliferative
diseases (MDS/MPD).
imatinib mesylate Novartis 021588 SE1 013   12/21/2005 10/19/2006 9.9 Provides for the treatment of adult Ph+ acute lymphoblastic leukemia (ALL)
monotherapy.
imatinib mesylate Novartis 021588 SE1 014   3/1/2006 10/19/2006 7.6 Provides for the treatment of adult aggressive systemic mastocytosis (ASM).
imatinib mesylate Novartis 021588 SE1 017   3/29/2006 10/19/2006 6.7 Provides for the treatment of adult hypereosinophilic syndrome/chronic
eosinophilic leukemia (HES/CEL).
quetiapine fumarate AstraZeneca 020639 SE1 026   12/30/2005 10/20/2006 9.7 Provides labeling in response to FDA's request that all manufacturers of atypical antipsychotic drug products add a Boxed Warning and a Bolded Warning section to labeling to advise that elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death.
posaconazole Schering 022027 N 000   12/22/2005 10/20/2006 9.9 Provides for the use of Noxafil (posaconazole) Oral Suspension for the
treatment of oropharyngeal candidiasis, including oropharyngeal candidiasis refractory to itraconazole and/or fluconazole.
rosiglitazone maleate; glimepiride GlaxoSmithKline 021700 SE1 003   12/20/2005 10/24/2006 10.1 Provides for additional clinical information for Avandaryl
(rosiglitazone maleate and glimepiride) Tablets in adult patients with type 2 diabetes mellitus who are
naive to pharmacologic therapy.
somatropin [rDNA origin] Lilly 019640 SE1 058   12/23/2005 11/1/2006 10.3 Provides for treatment of short stature or growth failure in children with SHOX (short stature homeobox-containing gene) deficiency whose epiphyses are not closed.
pramipexole dihydrochloride Boehringer Ingelheim 020667 SE1 013   7/28/2005 11/7/2006 15.4 Provides for the use of Mirapex (pramipexole dihydrochloride) Tablets for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS).
bortezomib Millennium 021602 SE1 010 Y 6/9/2006 12/8/2006 6.0 Provides for the use of Velcade (bortezomib) for injection for the treatment of patients with mantle cell lymphoma who have received at least 1 prior therapy.
paroxetine mesylate JDS 021299 SE1 017   3/13/2006 12/9/2006 8.9 Provides for the use of Pexeva (paroxetine mesylate) Tablets for Generalized Anxiety Disorder.
celecoxib Pfizer 020998 SE5 021 Y 6/22/2006 12/15/2006 5.8 Provides for the use of CELEBREX® (celecoxib) Capsules for the relief of the signs and symptoms of juvenile rheumatoid arthritis (JRA) in patients 2 years of age and older.
desflurane Baxter 020118 SE5 012 Y 6/26/2006 12/15/2006 5.7 Provides for the inclusion of data for the pediatric population ages 2-16 years.
balsalazide disodium Salix 020610 SE5 016 Y 6/20/2006 12/20/2006 6.0 Provides for the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older.  Safety and effectiveness of Colazal beyond 8 weeks in children (ages 5-17 years) and 12 weeks in adults have not been established.
emtricitabine Gilead Sciences 021896 SE5 001 Y 6/29/2006 12/22/2006 5.8 Provides for the inclusion of pharmacokinetic data for children from
birth to three months of age in the label.
exenatide Amylin 021773 SE1 002   2/28/2006 12/22/2006 9.8 Provides for the use of exenatide in patients with type 2 diabetes mellitus who are using a thiazolidinedione alone or in combination with metformin but
have not achieved adequate glycemic control.
estradiol; norethindrone acetate Novo Nordisk 020907 SE2 009   3/1/2006 12/28/2006 9.9 Provides for the use of Activella® (estradiol/norethindrone acetate) tablets
0.5 mg/0.1 mg for the treatment of moderate to severe vasomotor symptoms associated with menopause in women who have a uterus.
estradiol; norethindrone acetate Novo Nordisk 022001 N 000   3/1/2006 12/29/2006 10.0 Provides for the use of Activella (estradiol/norethindrone acetate) Tablets, 0.5 mg/0.1 mg for prevention of postmenopausal osteoporosis.

 

NDA Efficacy Supplements Approved (SE8)

Established Name Applicant NDA Number Supp Type Supp Number Priority Review Receipt Date Approval Date Total Approval Time (Months)
gemtuzumab ozogamicin Wyeth 021174 SE8 020   3/23/2005 1/23/2006 10.1
thyrotropin alfa Genzyme 020898 SE8 031   3/23/2005 1/24/2006 10.1
risedronate sodium Proctor & Gamble 020835 SE8 019   3/24/2005 1/24/2006 10.1