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Efficacy Supplement Approvals in 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