New Drug Application (NDA) & Biologic License Application (BLA) Efficacy CY 2007

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New Drug Application (NDA) & Biologic License Application (BLA) Efficacy Supplements Approved (CY 2007)
Updated through December 31, 2007

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
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).

NDA Efficacy Supplements Approved (SE8)

Established Name	Applicant	NDA Number	Supp Type	Supp Number	Priority Review	Receipt Date	Approval Date	Total Approval Time (Months)
oxaliplatin	Sanofi Aventis	021492	SE8	008	Y	07/10/06	01/10/07	6.0
cilostazol	Otsuka	020863	SE8	019		10/13/05	01/18/07	15.2
insulin aspart (rDNA)	Novo Nordisk	020986	SE8	037		03/27/06	01/26/07	10.0
azacitidine	Pharmion	050794	SE8	005		03/29/06	01/26/07	10.0
sunitinib malate	Pfizer	021938	SE8	005	Y	08/11/06	02/02/07	5.8
sunitinib malate	Pfizer	021938	SE8	004	Y	08/11/06	02/02/07	5.8
sunitinib malate	Pfizer	021938	SE8	003		08/02/06	02/02/07	6.0
sunitinib malate	Pfizer	021968	SE8	006	Y	08/11/06	02/02/07	5.8
sunitinib malate	Pfizer	021968	SE8	004		04/03/06	02/02/07	10.0
sunitinib malate	Pfizer	021968	SE8	003		04/03/06	02/02/07	10.0
paclitaxel protein-bound particles	Abraxis BioScience	021660	SE8	010		04/18/06	02/15/07	10.0
bosentan	Actelion Clinical Research	021290	SE8	010		04/18/06	02/15/07	10.0
entecavir	Bristol-Myers Squibb	021798	SE8	001		02/24/06	02/23/07	12.0
entecavir	Bristol-Myers Squibb	021797	SE8	001		02/24/06	02/23/07	12.0
pioglitazone hydrochloride	Takeda	021073	SE8	026		01/26/06	02/25/07	13.0
pravastatin sodium	Bristol-Myers Squibb	019898	SE8	060		05/01/06	02/28/06	10.0
imiquimod	Graceway	020723	SE8	020	Y	09/22/06	03/22/07	6.0
dipyridamole	Boehringer Ingelheim	020884	SE8	012		03/02/06	03/26/07	12.8
lopinavir;ritonavir	Abbott	021226	SE8	018		06/20/06	04/20/07	10.0
lopinavir;ritonavir	Abbott	021251	SE8	012		06/20/06	04/20/07	10.0
lopinavir;ritonavir	Abbott	021906	SE8	002		06/20/06	04/20/07	10.0
mequinol;tretinoin	Barrier	020922	SE8	003		06/29/06	04/25/07	9.9
imatinib mesylate	Novartis	021588	SE8	020		08/01/06	09/13/07	13.4
atomoxetine hydrochloride	Lilly	021411	SE8	019		12/01/06	09/28/07	9.9
bortezomib	Millennium	021602	SE8	013		12/12/06	10/10/07	9.9
sitagliptin phosphate	Merck & Co	021995	SE8	002		12/12/06	10/12/07	10.0
sitagliptin phosphate	Merck & Co	021995	SE8	003		12/15/06	10/12/07	9.9
sevelamer hydrochloride	Genzyme	021179	SE8	020		12/19/06	10/19/07	10.0
dasatinib	Bristol-Myers Squibb	021986	SE8	002		05/11/07	11/08/07	6.0
sinecatechins	MediGene	021902	SE8	002		02/27/07	12/19/07	9.7
paliperidone ER	Johnson & Johnson	021999	SE8	001		02/27/07	12/21/07	9.8

BLA Efficacy Supplements Approved

Proper Name	Applicant	BLA Number	Supp Number	Priority Review	Receipt Date	Approval Date	Total Approval Time (Months)	Indication/Description
adalimumab	Abbott	125057	60.0		04/19/06	02/16/07	10.0	Revisions to the PRECAUTIONS section of the package insert to add language regarding the impact of adalimumab on pneumococcal and influenza vaccine immunizations in rheumatoid arthritis patients
adalimumab	Abbott	125057	89.0	Y	08/28/06	02/27/07	6.0	Treatment of moderately to severely active Crohn's disease in adult patients who have had an inadequate response to conventional therapy, and who have lost response to or are intolerant to infliximab
abatacept	Bristol-Myers Squibb	125118	16.0		05/18/06	03/13/20	9.8	Revision to the indication based upon two-year radiographic data.
infliximab	Centocor	103772	5260.0		06/20/06	04/19/07	10.0	Revision to include safety information for Juvenile Rheumatoid Arthritis (JRA) in the label (PMC #3 under 103772/1004)
drotrecogin alfa	Eli Lilly	125029	87.0		06/20/06	04/27/07	10.2	Revisions to the CLINICAL PHARMACOLOGY, CLINICAL STUDIES and ADVERSE REACTIONS sections of the label to include low-dose heparin use information.
adalimumab	Abbott	125057	94.0		09/29/06	07/30/07	10.0	Update labeling to include long-term maintenance to the Clinical Studies section with respect to clinical response, physical function and radiographic response in patients with rheumatoid arthritis, has been approved.
campath	Genzyme	103948	5070.0	Y	03/20/2007	09/19/07	6.0	Treatment of B-cell chronic lymphocytic leukemia (B-CLL) in patients who have been treated with alkylating agents and who have failed fludarabine therapy.
centuximab	ImClone	125084	103.0	Y	04/2/07	10/02/07	6.0	Expand the colorectal cancer indication to include cetuximab as a single agent in patients with EGFR-expressing, metastatic colorectal cancer after failure of both irinotecan and oxaliplatin-based regimens.

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 12/31/2007

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Last Updated: March 6, 2008