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 New Drug Application (NDA) & Biologic License Application (BLA) Efficacy Supplements Approved (CY 2005)

 

            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

Review Class

Receipt Date

 Approval Date Total Approval Time (Months)

Indication / Description
ciprofloxacin Bayer 020780 SE7 016 S 3/8/2004 1/7/2005 10.0 Provides for changes to the INDICATIONS AND USAGE, ADVERSE REACTIONS, and INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION sections of the package insert based on the information obtained from the Centers for Disease Control and Prevention program evaluation conducted after the bioterror events of October 2001
ciprofloxacin Bayer 019857 SE7 035 S 3/8/2004 1/7/2005 10.0 Provides for changes to the INDICATIONS AND USAGE, ADVERSE REACTIONS, and INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION sections of the package insert based on the information obtained from the Centers for Disease Control and Prevention program evaluation conducted after the bioterror events of October 2001
ciprofloxacin Bayer 019847 SE7 030 S 3/8/2004 1/7/2005 10.0 Provides for changes to the INDICATIONS AND USAGE, ADVERSE REACTIONS, and INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION sections of the package insert based on the information obtained from the Centers for Disease Control and Prevention program evaluation conducted after the bioterror events of October 2001
ciprofloxacin hydrochloride Bayer 019537 SE7 052 S 3/8/2004 1/7/2005 10.0 Provides for changes to the INDICATIONS AND USAGE, ADVERSE REACTIONS, and INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION sections of the package insert based on the information obtained from the Centers for Disease Control and Prevention program evaluation conducted after the bioterror events of October 2001
norethindrone acetate; ethinyl estradiol Warner Chilcott 021065 SE2 012 S 3/15/2004 1/14/2005 10.0 Provides for the use of femhrt® 0.5 mg/2.5 mcg (norethindrone acetate/ethinyl estradiol tablets) in women with an intact uterus for the: 1. Treatment of moderate to severe vasomotor symptoms associated with the menopause. 2. Prevention of postmenopausal osteoporosis.
doxorubicin hydrochloride Alza 050718 SE7 020 S 3/29/2004 1/28/2005 10.0 Provides for the use of Doxil® for the treatment of patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy.
fentanyl Alza 019813 SE2 039 S 4/6/2004 2/4/2005 10.0 Provides for the use of Duragesic® (Fentanyl Transdermal System) 12 mcg/h patch for the management of persistent, moderate to severe chronic pain that: requires continuous, around-the-clock opioid administration for an extended period of time, and cannot be managed by other means such as non-steroidal analgesics, opioid combination products, or immediate-release opioids.
metoprolol succinate AstraZeneca 019962 SE2 027 S 4/30/2004 2/15/2005 9.6 Provides for the broadening of the initial starting dose in hypertension of metoprolol succinate ER from the current 50 to 100 mg approved dose to 25 mg to 100 mg dose range.
candesartan cilexetil AstraZeneca 020838 SE1 024 P 6/30/2004 2/22/2005 7.8 Provides for the use of Atacand® (candesartan cilexetil) 4, 8, 16, and 32 mg Tablets for the treatment of heart failure (NYHA class II-IV and ejection fraction ≤40%) to reduce the risk of death from cardiovascular causes and to reduce hospitalizations for heart failure.
ribavirin Roche 021511 SE1 005 P 8/26/2004 2/25/2005 6.0 Provides for the use of Copegus® (ribavirin) 200 mg tablet for the treatment of chronic hepatitis C in adult patients coinfected with human immunodeficiency virus (HIV) in combination with Pegasys® (peginterferon alfa-2a).
rosiglitazone GlaxoSmithKline 021071 SE1 012 S 4/30/2004 2/28/2005 10.0 Provides for the use of Avandia 8 mg per day (a new higher strength) in combination with a sulfonylurea to treat patients with type 2 diabetes mellitus and for the use of Avandia 4 mg and 8 mg per day in combination with a sulfonylurea and metformin (triple therapy).
aripiprazole Otsuka 021436 SE1 005 S 1/30/2004 3/1/2005 13.0

Provides for the use of Abilify® Tablets as maintenance therapy in Bipolar I Disorder
aripiprazole Otsuka 021713 SE1 003 S 2/16/2005 3/1/2005 0.4

Provides for the use of Abilify® Oral Solution as maintenance therapy in Bipolar I Disorder
sirolimus Wyeth 021083 SE5 019 P 9/13/2004 3/11/2005 5.9

Provides for the addition of pediatric pharmacokinetics information to the labeling along with results of a clinical study in pediatric patients <18 years of age at high immunologic risk for acute rejection (oral solution).
sirolimus Wyeth 021110 SE5 024 P 9/13/2004 3/11/2005 5.9 Provides for the addition of pediatric pharmacokinetics information to the labeling along with results of a clinical study in pediatric patients <18 years of age at high immunologic risk for acute rejection (tablets).
temozolomide Schering 021029 SE1 008 P, O 9/15/2004 3/15/2005 6.0

Provides clinical support for the use of Temodar Capsules for the treatment of patients with newly diagnosed high grade gliomas concomitantly with radiotherapy and then as adjuvant treatment.
micafungin sodium Fujisawa Healthcare 021754 N 000 S 4/26/2004 3/16/2005 10.7

Provides for the use of Mycamine™ (micafungin sodium) for Injection, for the treatment of esophageal candidiasis.
ibandronate sodium Roche 021455 SE2 001 S 5/25/2004 3/24/2005 10.0

Provides for once-monthly treatment of postmenopausal osteoporosis with Boniva (ibandronate sodium) 150 mg Tablets.
bortezomib Millennium 021602 SE1 006 P, O 9/28/2004 3/25/2005 5.9

Provides for the use of Velcade (bortezomib) for Injection for treatment of multiple myeloma patients who have received as least one prior therapy.
ondansetron GlaxoSmithKline 020007 SE5 035 P 9/29/2004 3/25/2005 5.8 Provides for updating the label with new pediatric information.
budesonide AstraZeneca 021324 SE1 005 S 7/1/2004 4/29/2005 9.9 Provides for the use of Entocort EC (budesonide) Capsules, 3 mg for the maintenance of clinical remission of mild to moderate Crohn’s disease involving the ileum and/or the ascending colon for up to 3 months.
lopinavir; ritonavir Abbott 021226 SE2 016 S 7/1/2004 4/29/2005 9.9 Provides for the use of Kaletra 800/200mg once-daily administration for the treatment of HIV- infection in therapy-naïve adult patients.
carvedilol GlaxoSmithKline 020297 SE1 013 S 1/20/2004 4/29/2005 15.3 Provides for the revision of the package insert to include the results of the COMET trial for Coreg (carvedilol) 3.125, 6.25, 12.5 and 25 mg Tablets.
ropinirole hydrochloride GlaxoSmithKline 020658 SE1 013 P 7/7/2003 5/4/2005 22.1 Provides for the use of Requip (ropinirole HCl) Tablets for Restless Legs Syndrome (RLS).
azelaic acid Berlex 021470 SE1 003 S 12/18/2003 5/5/2005 16.6 Provides for a qualified reduction of erythema during the topical treatment of inflammatory papules and pustules of mild to moderate rosacea.
abacavir sulfate; lamivudine; zidovudine GlaxoSmithKline 021205 SE7 011 S 7/16/2004 5/13/2005 9.9 Provides for the use of Trizivir Tablets in combination with other antiretroviral agents or alone for the treatment of HIV-1 infection.
ethinyl estradiol; norgestimate Ortho-McNeil 021690 N 000 P 11/19/2004 5/13/2005 19.6 Provides for revision to the Pediatric Use subsection of the PRECAUTIONS
section of the prescribing information for Ortho TriCyclen to incorporate the results from the CAPPS-169 study entitled “The Effect of Ortho TriCyclen on Bone Mineral Density in Pediatric Subjects with Anorexia Nervosa”.
ertapenem sodium Merck 021337 SE1 018 P 11/22/2004 5/18/2005 5.8 Provides for the use of Invanz (ertapenem for injection) in the pediatric population.
candesartan cilexetil AstraZeneca 020838 SE1 022 P 3/18/2005 5/18/2005 10.6 Provides for the use of Atacand (candesartan cilexetil) 4, 8, 16, and 32 mg Tablets for the treatment of heart failure (NYHA class II-IV) in patients with left
ventricular systolic dysfunction (ejection fraction <40%) to reduce cardiovascular death and to reduce heart failure hospitalizations. Atacand also has an added effect on these outcomes when used with an ACE inhibitor.
sodium iodide I-131 Draximage 021305 SE1 003 S 7/19/2004 5/19/2005 10.0 Provides for the use of Sodium Iodide I 131 Capsules USP (diagnostic oral) in performance of the radioactive iodide (RAI) uptake test to evaluate thyroid function. Diagnostic doses may also be employed in localizing metastases associated with thyroid malignancies.
meropenem AstraZeneca 050706 SE1 018 S 7/28/2004 5/25/2005 9.9 Provides for the use of meropenem, 500 mg IV every 8 hours, as treatment for patients with complicated skin and skin structure infections (cSSSI) due to
Staphylococcus aureus (methicillin susceptible strains), Streptococcus pyogenes, Streptococcus agalactiae, viridans group streptococci, Enterococcus faecalis, Pseudomonas aeruginosa, Escherichia coli, Proteus mirabilis, Bacteroides fragilis, and Peptostreptococcus species.
fondaparinux sodium GlaxoSmithKline 021345 SE1 010 S 7/30/2004 5/26/2005 9.9 Provides for the use of Arixtra (fondaparinux sodium, injection) in patients undergoing abdominal surgery who are at risk for thromboembolic complications.
pregabalin Pfizer 021724 N 000 S 10/31/2003 6/10/2005 19.3 Provides for the use of Lyrica (pregabalin) 25, 50, 75, and 100, 150, 200,
225, and 300-mg capsules as adjunctive therapy for adult patients with partial onset seizures.
moxifloxacin hydrochloride Bayer 021277 SE1 022 S 8/13/2004 6/13/2005 10.0 Provides for the use of AVELOX® (moxifloxacin hydrochloride in NaCl injection) I.V. for the treatment of adults (≥ 18 years of age) with complicated skin and skin structure infections caused by methicillin susceptible Staphylococcus aureus, Escherichia coli, Klebsiella pneumoniae, and Enterobacter cloacae.
moxifloxacin hydrochloride Bayer 021085 SE1 026 S 8/13/2004 6/13/2005 10.0 Provides for the use of AVELOX® (moxifloxacin hydrochloride) Tablets for the treatment of adults (≥ 18 years of age) with complicated skin and skin structure infections caused by
methicillin susceptible Staphylococcus aureus, Escherichia coli, Klebsiella pneumoniae, and Enterobacter cloacae.
bivalirudin Medicines Company 020873 SE1 006 S 7/28/2003 6/13/2005 22.6 Provides for the use of Angiomax® (bivalirudin) for Injection with provisional use of glycoprotein IIb/IIIa inhibitor (GPI) as listed in the CLINICAL
TRIALS REPLACE-2 section for use as an anticoagulant in patients undergoing percutaneous coronary intervention (PCI).
capecitabine Hoffmann-La Roche 020896 SE1 016 S 8/18/2004 6/15/2005 9.9 Provides for the use of XELODA (Capcitabine) oral tablets as a single agent for adjuvant treatment in patients with Dukes’ C colon cancer who have undergone complete resection of the primary tumor when treatment with fluoropyrimidine therapy alone is preferred.
nitazoxanide Romark 021818 N 000 P 5/29/2002 6/16/2005 36.6 Provides for the use Alinia® (nitazoxanide) Tablets for the treatment of diarrhea caused by Cryptosporidium parvum in non-HIV infected patients 12 years of age and older.
nitazoxanide Romark 021498 SE5 003 P 12/20/2004 6/16/2005 5.9 Provides for the use of Alinia®
(nitazoxanide) for Oral Suspension for the treatment of diarrhea caused by Cryptosporidium parvum in non-HIV infected patients 12 years of age and older.
iron sucrose Luitpold 021135 SE1 008 S 8/18/2003 6/17/2005 22.0 Provides for the use of Venofer® (Iron Sucrose Injection, USP) for the treatment of iron deficiency anemia in the following patients: • non-dialysis dependent chronic kidney disease (NDD-CKD) patients receiving an erythropoietin
• non-dialysis dependent chronic kidney disease (NDD-CKD) patients not receiving an erythropoietin.
levetiracetam UCB 021505 SE5 007 P 12/21/2004 6/21/2005 6.0 Provides for the use of Keppra (levetiracetam) oral solution as adjunctive therapy in the treatment of partial onset seizures in children 4 years of age and older with epilepsy.
levetiracetam UCB 021035 SE5 040 P 12/21/2004 6/21/2005 6.0 Provides for the use of Keppra (levetiracetam) tablets as adjunctive therapy in the treatment of partial onset seizures in children 4 years of age and older with epilepsy.
somatropin Genentech 019676 SE1 020 S 12/22/2003 6/28/2005 18.2 Provides for the long-term treatment of idiopathic short stature.
somatropin Genentech 020522 SE1 021 S 2/2/2004 6/28/2005 16.8 Provides for the long-term treatment of idiopathic short stature.
topiramate Ortho-McNeil 020505 SE1 018 S 10/30/2002 6/29/2005 32.0 Provides for the use of Topamax (topiramate) Tablets as initial monotherapy in patients 10 years of age and older with partial onset or primary generalized tonic-clonic seizures.
topiramate Ortho-McNeil 020844 SE1 015 S 10/30/2002 6/29/2005 32.0 Provides for the use of Topamax (topiramate) Sprinkle Capsules as initial monotherapy in patients 10 years of age and older with partial onset or primary generalized tonic-clonic seizures.
mixed salts of a single-entity amphetamine Shire 021303 SE5 009 P 9/17/2004 7/21/2005 10.1 Provides for the use of Adderall XR in the treatment of adolescents with attention-deficit hyperactivity disorder.
montelukast sodium Merck 021409 SE1 012 S 9/30/2004 7/27/2005 9.9 Provides for the use of Singulair (montelukast sodium) Oral Granules for the relief of symptoms of perennial allergic rhinitis (PAR) in adults and pediatric patients 6 months of age and older.
montelukast sodium Merck 020830 SE1 035 S 9/30/2004 7/27/2005 9.9 Provides for the use of Singulair (montelukast sodium) Chewable Tablets for the relief of symptoms of perennial allergic rhinitis (PAR) in adults and pediatric patients 6 months of age and older.
montelukast sodium Merck 020829 SE1 033 S 9/30/2004 7/27/2005 9.9 Provides for the use of Singulair (montelukast sodium) Tablets for the relief of symptoms of perennial allergic rhinitis (PAR) in adults and pediatric patients 6 months of age and older.
rosiglitazone GlaxoSmithKline 021071 SE5 015 P 9/30/2004 7/29/2005 9.9

Provides for changes to the labeling describing the results of a study comparing the effects of Avandia to those of metformin in children with type 2 diabetes mellitus, aged 10-17 years. An indication for the use of Avandia in this population is not supported by the results of the study.
celecoxib Pfizer 020998 SE1 018 S 10/1/2004 7/29/2005 9.9 Provides for the use of Celebrex® (celecoxib) capsules for the relief of signs and symptoms of ankylosing spondylitis.
valsartan Novartis 021283 SE1 011 S 12/17/2003 8/3/2005 19.6 Provides for the use of Diovan (valsartan) 40, 80, 160, and 320 mg Tablets in the treatment of patients post-myocardial infarction. In clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction, Diovan is
indicated to reduce cardiovascular mortality.
levofloxacin Ortho McNeil 021721 SE2 002 S 11/2/2004 8/4/2005 9.0 Provides for the use of Levaquin® (levofloxacin) 750 mg Oral Solution once daily for five days for the treatment of acute bacterial sinusitis.
levofloxacin Ortho McNeil 020635 SE2 038 S 11/2/2004 8/4/2005 9.0 Provides for the use of Levaquin® (levofloxacin or levofloxacin in 5% dextrose) Injection once daily for five days for the treatment of acute bacterial sinusitis.
levofloxacin Ortho McNeil 020634 SE2 037 S 11/2/2004 8/4/2005 9.0 Provides for the use of Levaquin® (levofloxacin) Tablets once daily for five days for the treatment of acute bacterial sinusitis.
meloxicam Boehringer Ingelheim 021530 SE1 001 P, O 2/18/2005 8/11/2005 5.7 Provides for the use of Mobic Oral Suspension for relief of the signs and symptoms of pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis in patients 2 years of age and older.
meloxicam Boehringer Ingelheim 020938 SE1 013 P, O 2/18/2005 8/11/2005 5.7 Provides for the use of Mobic Tablets for relief of the signs and symptoms of pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis in patients 2 years of age and older.
fludeoxyglucose F18 North Shore/LIJ Research Institute 021870 N 000 S 11/19/2004 8/19/2005 9.0 Provides for the use of Fludeoxyglucose F 18 Injection: 1. In positron emission tomography (PET) imaging for assessment of abnormal glucose
metabolism to assist in the evaluation of malignancy in patients with known or suspected abnormalities found by other testing modalities, or in patients with an existing diagnosis of cancer.  2. In positron emission tomography (PET) imaging in patients with coronary artery disease and left ventricular dysfunction, when used together with myocardial perfusion imaging, for the identification of left ventricular myocardium with residual glucose metabolism and
reversible loss of systolic function.  3. In positron emission tomography (PET) imaging in patients for the identification of regions of abnormal glucose metabolism associated with foci of epileptic seizures.
perindopril erbumine Solvay 020184 SE1 011 P 12/10/2004 8/23/2005 8.4 Provides for the use of Aceon® 2, 4 and 8 mg Tablets in patients with stable coronary artery disease to reduce the risk of cardiovascular mortality or non-fatal myocardial infarction.
iloprost CoTherix 021779 SE1 001 S 4/27/2005 8/24/2005 3.9 Provides inclusion of the results of “A Placebo-Controlled Study to Evaluate the Safety and Pilot Efficacy of Iloprost Inhalation Solution as Add-On Therapy
with Bosentan in Subjects with Pulmonary Arterial Hypertension”.
insulin aspart Novo Nordisk 020986 SE5 033 P 3/15/2005 9/13/2005 6.0

Provides for revision to the Pediatric Use subsection of the PRECAUTIONS section of the package insert for the use of NovoLog in patients 6 through 18 years old.
anastrozole AstraZeneca 020541 SE7 016 S 11/18/2004 9/16/2005 9.9

Provides the updated report of the ATAC data as requested in a subpart H commitment associated with the approval of supplemental application 010.
atorvastatin calcium Pfizer 020702 SE1 042 S 12/20/2004 9/21/2005 9.0

Provides for the use of atorvastatin in adult patients with type 2 diabetes and without clinically evident coronary heart disease (but with multiple risk factors for coronary heart disease such as retinopathy, albuminuria, smoking, or hypertension), to reduce the risk of myocardial infarction and stroke. It's also indicated to reduce the risk of stroke in adult patients without clinically evident coronary heart disease but with multiple risk factors for coronary heart disease such as age, smoking, hypertension, low HDL-C, or a family history of early coronary heart disease.  The post-marketing adverse event “fatigue” was added to the ADVERSE REACTIONS section of the label.
amlodipine besylate Pfizer 019787 SE1 038 S 4/1/2005 9/28/2005 5.9 Proposes changes to the package insert for the use of Norvasc (amlodipine besylate) Tablets in patients with angiographically documented coronary artery disease.
exemestane Pfizer 020753 SE1 006 S 12/9/2004 10/5/2005 9.9 Provides for the use of Aromasin® (exemestane) Tablets, 25 mg for adjuvant treatment of postmenopausal women with estrogen-receptor positive early breast cancer who have received two to three years of tamoxifen and are switched to AROMASIN® for completion of a total of five consecutive years of adjuvant hormonal therapy.
ritonavir Abbott 020659 SE5 034 P 4/7/2005 10/6/2005 6.0 Provides for the use of NORVIR (ritonavir) oral solution in combination with other antiretroviral agents for the treatment of HIV-infection in pediatric patients from one month to two years of age.
ritonavir Abbott 020945 SE5 017 P 4/7/2005 10/6/2005 6.0 Provides for the use of NORVIR (ritonavir) soft gelatin capsules in combination with other antiretroviral agents for the treatment of HIV-infection in pediatric patients from one month to two years of age.
fexofenadine hydrochloride Aventis 020872 SE2 015 S 12/14/2004 10/13/2005 10.0 Provides for Allegra (fexofenadine) 180 mg tablets used once daily in chronic idiopathic urticiaria (CIU).
ertapenem sodium Merck 021337 SE1 019 S 12/17/2004 10/14/2005 9.9 Provides for the use of INVANZ® (ertapenem sodium) in the treatment of adult diabetic foot infections without osteomyelitis.
iron sucrose Luitpold 021135 SE1 013 S 12/17/2004 10/17/2005 10.0 Provides for the use of Venofer (iron sucrose injection, USP) for treatment of iron deficiency anemia in peritoneal dialysis dependent-chronic kidney disease (PDD-CKD) patients receiving an erythropoietin.
insulin detemir (rDNA origin) Novo Nordisk 021878 N 000 S 12/20/2004 10/19/2005 10.0 Provides for the use of Levemir (insulin detemir) in pediatric patients with type 1 diabetes.
losartan potassium; hydrochlorothiazide Merck 020387 SE2 037 S 12/20/2004 10/20/2005 10.0 Provides for registration of a losartan 100 mg and hydrochlorothiazide
12.5 mg fixed-dose combination tablet.
insulin (rDNA origin) Novo Nordisk 019938 SE3 048 S 12/23/2004 10/21/2005 9.9 Provides for label revisions to include the intravenous administration of Novolin R (regular, human insulin [rDNA origin] injection) under proper medical supervision in a clinical setting for the treatment of patients with diabetes mellitus.
insulin aspart Novo Nordisk 020986 SE3 032 S 12/23/2004 10/21/2005 9.9 Provides for label revisions to include the intravenous administration of NovoLog (insulin aspart [rDNA origin] injection) under proper medical supervision in a clinical setting for the
treatment of patients with diabetes mellitus.
oxcarbazepine Novartis 021285 SE5 008 P 12/14/2004 10/28/2005 10.5 Provides for the use of Trileptal (oxcarbazepine) oral solution for use as adjunctive therapy in the treatment of partial seizures in children with epilepsy aged two to four years.
oxcarbazepine Novartis 021014 SE5 013 P 12/14/2004 10/28/2005 10.5 Provides for the use of Trileptal (oxcarbazepine) tablets for use as adjunctive therapy in the treatment of partial seizures in children with epilepsy aged two to four years.
aprepitant Merck 021549 SE1 008 S 9/29/2004 10/28/2005 13.0 Provides for the use of Emend (aprepitant) in the prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.
erlotinib hydrochloride OSI 021743 SE1 003 P 5/2/2005 11/2/2005 6.0 Provides for the use of Tarceva (erlotinib) tablets in combination with gemcitabine for the first-line treatment of patients with locally advanced,
unresectable or metastatic pancreatic cancer.
fluocinolone acetonide Hill Dermac 021930 N 000 P 5/9/2005 11/9/2005 6.0 Provides for the use of fluocinolone acetonide oil, 0.01% ear drops for
treatment of chronic eczematous external otitis.
venlafaxine hydrochloride Wyeth 020699 SE1 054 S 9/29/2004 11/18/2005 13.6 Provides for the use of Effexor XR in the treatment of short-term panic disorder.
venlafaxine hydrochloride Wyeth 020699 SE1 057 S 9/29/2004 11/18/2005 13.6 Provides for the use of Effexor XR in the treatment of long-term panic disorder.
sodium oxybate Orphan Medical 021196 SE1 005 S 1/18/2005 11/18/2005 10.0 Provides for the use of Xyrem ® (sodium oxybate) oral solution for the treatment of excessive daytime sleepiness in patients with narcolepsy.
moxifloxacin hydrochloride Bayer 021085 SE1 027 S 2/1/2005 11/22/2005 9.7 Provides for a change in the product labeling to include the use of Avelox® (moxifloxacin hydrochloride) Tablets for the treatment of complicated intra-abdominal infections caused by specified bacteria.
moxifloxacin hydrochloride Bayer 021277 SE1 024 S 1/31/2005 11/22/2005 9.7 Provides for a change in the product labeling to include the use of Avelox® (moxifloxacin hydrochloride in NaCl injection) I.V. for the treatment of complicated intra-abdominal infections caused by specified bacteria.
glimepiride Aventis 020496 SE5 015 P 3/15/2005 11/28/2005 8.5 Provides for changes to the following sections of the Amaryl (glimepiride) Tablets package insert: CLINICAL PHARMACOLOGY-Special Populations-Pediatric; PRECAUTIONS-Pediatric Use; Adverse Reactions-Pediatric patients
bivalirudin Medicines Company 020873 SE1 011 S 1/31/2005 11/30/2005 10.0 Provides for the use of Angiomax® (bivalirudin) for Injection for patients with, or at risk of, HIT/HITTS undergoing PCI.
venlafaxine hydrochloride Wyeth 020699 SE5 059 S 12/2/2004 12/1/2005 12.0 Provides for additional safety data for changes in weight, height, and appetite occurring in pediatric patients with social anxiety disorder treated with Effexor XR.
divalproex sodium Abbott 021168 SE1 012 S 10/26/2004 12/6/2005 13.3 Proposes the use of Depakote ER as monotherapy in the treatment of acute
manic or mixed episodes associated with bipolar I disorder, with or without psychotic features.
sibutramine hydrocholoride Abbott 020632 SE5 021 P 6/22/2004 12/8/2005 17.6 Provides for labeling changes to the Meridia (sibutramine hydrochloride monohydrate) Capsules Package Insert (PI).
oseltamivir phosphate Roche 021087 SE5 030 S 4/18/2005 12/21/2005 8.1 Provides for the use of Tamiflu (oseltamivir phosphate) Capsules for prophylaxis of influenza for patients between 1-12 years of age.
oseltamivir phosphate Roche 021246 SE5 017 S 4/18/2005 12/21/2005 8.1 Provides for the use of Tamiflu (oseltamivir phosphate) Oral Suspension for prophylaxis of influenza for patients between 1-12 years of age.
alendronate sodium Merck 020560 SE1 038 P 11/3/2004 12/21/2005 34.7 Provides for information in the Clinical Pharmacology and ADVERSE REACTIONS sections concerning an osteogenesis imperfecta study, and update the Precautions section with the statement that FOSAMAX is not indicated for use in children.
estradiol; levonorgestrel Berlex 021885 N 000 S 3/1/2005 12/27/2005 9.9 Provides for the use of Climara Pro (estradiol/levonorgestrel) Transdermal
System for the prevention of postmenopausal osteoporosis.
letrozole Novartis 020726 SE1 012 P 6/28/2005 12/28/2005 6.0 Provides for the use of Femara® (letrozole tablets) for the adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer.

NDA Efficacy Supplements Approved (SE8)

Established Name Applicant NDA Number Supp Type Supp Number Review
Class		 Receipt Date Approval Date Total Approval Time (Months)
alosetron hydrochloride

GlaxoSmithKline

 021107 SE8 009 S 3/31/2004 1/31/2005 10.0
telithromycin Aventis 021144 SE8 001 S 4/9/2004 2/9/2005 10.0
caspofungin acetate Merck 021227 SE8 015 S 4/16/2004 2/16/2005 10.0
epirubicin hydrochloride Pfizer 050778 SE8 008 S 5/3/2004 3/2/2005 10.0
imatinib mesylate Novartis 021588 SE8 005 S 9/8/2004 3/14/2005 6.1
hydrochlorothiazide; losartan potassium Merck 020387 SE8 033 S 7/8/2004 4/5/2005 8.9
lovastatin Merck 019643 SE8 075 S 7/1/2004 4/7/2005 9.2
gemcitabine hydrochloride Lilly 020509 SE8 033 P 10/27/2004 4/26/2005 6.0
linezolid Pharmacia & Upjohn 021130 SE8 009 P 12/17/2004 5/12/2005 4.8
linezolid Pharmacia & Upjohn 021131 SE8 010 P 12/17/2004 5/12/2005 4.8
linezolid Pharmacia & Upjohn 021132 SE8 010 P 12/17/2004 5/12/2005 4.8
tenofovir disoproxil fumarate Gilead 021356 SE8 011 S 7/13/2004 5/12/2005 10.0
atomoxetine hydrochloride Lilly 021411 SE8 008 S 7/29/2004 5/26/2005 9.9
amoxicllin; clavulanate potassium GlaxoSmithKline 050785 SE8 006 S 5/17/2004 6/15/2005 13.0
oxandrolone Savient 013718 SE8 023 S 8/26/2002 6/20/2005 33.8
budesonide AstraZeneca 020929 SE8 022 S 9/2/2004 6/30/2005 9.9
etonogestrel; ethinyl estradiol Organon 021187 SE8 012 S 9/30/2004 7/29/2005 9.9
testosterone Unimed 021015 SE8 011 S 7/1/2004 8/11/2005 13.3
intrauterine copper FEI 018680 SE8 060 S 11/3/2004 9/1/2005 9.9
somatropin, biosynthetic Lilly 019640 SE8 045 S 12/15/2004 10/12/2005 9.9
imatinib mesylate Novartis 021588 SE8 008 S 12/23/2004 10/20/2005 9.9
tolterodine Pharmacia & Upjohn 021228 SE8 007 S 12/22/2004 10/20/2005 9.9
fenofibrate Reliant 021695 SE8 001 S 12/23/2004 10/21/2005 9.9
fluocinolone acetonide Hill Dermac 019452 SE8 019 S 4/2/2003 11/9/2005 31.3
fluocinolone acetonide Hill Dermac 019452 SE8 020 S 4/2/2003 11/9/2005 31.3
somatropin (rDNA origin) Genentech 020522 SE8 027 S 1/24/2005 11/18/2005 9.8
insulin aspart Novo Nordisk 021172 SE8 021 S 1/21/2005 11/21/2005 10.0
bosentan Actelion 021290 SE8 006 S 3/21/2005 11/29/2005 8.3
montelukast sodium Merck 021409 SE8 014 S 1/31/2005 11/30/2005 10.0
montelukast sodium Merck 020830 SE8 036 S 1/31/2005 11/30/2005 10.0
montelukast sodium Merck 020829 SE8 034 S 1/31/2005 11/30/2005 10.0

  BLA Efficacy Supplements Approved

Proper Name Applicant BLA Number Supp Number Priority Review Receipt Date Approval Date Total Approval Time (Months)

Indication/Description
alteplase Genentech BL103172 5071.0 S 5/4/2004 1/4/2005 8.0

Update the Clinical Studies, Pediatric Use, Adverse Reactions, and Dosage and Administration sections of the package insert with pediatric safety and efficacy data
peginterferon alfa-2a Hoffmann-La Roche BL 103964 5039 P 8/30/2004 2/25/2005 5.8 Expanded indication of Peginterferon alfa-2a (PEGASYS) alone or in combination with ribavirin USP (COPEGUS) to include treatment of adult chronic hepatitis C patients co-infected with HIV, who have clinically stable HIV disease
infliximab Centocor BL 103772 5089 S 7/30/2004 5/13/2005 9.5 Expands the indication to include treatment of psoriatic arthritis
peginterferon alfa-2a Hoffmann-La Roche BL 103964 5037 S 7/13/2004 5/13/2005 10.0 Treatment of adult patients with HBe Antigen positive and HBe Antigen negative chronic hepatitis B who have compensated liver disease and evidence of viral replication and liver inflammation
becaplermin OMJ BL 103691 5015 S 5/2/2003 5/13/2005 24.4 Revises the Clinical Studies and Precautions sections of the package insert to include information regarding the treatment of venous stasis and pressure ulcers, to add a Geriatric Use subsection, and to withdraw the 7.5 gram dose
etanercept Immunex BL 103795 5191 S 8/30/2004 5/27/2005 8.9 Revises the Indications and Usage and Clinical Studies sections of the package insert based on 2 year follow-up efficacy, safety, radiographic and physical function data
ibritumomab tiuxetan Biogen BL 125019 88 S 9/27/2004 7/27/2005 10.0 Revise the Dosage and Administration section of the package insert by reducing the number of scans required to assess biodistribution prior to administration of 90Y-Ibritumomab tiuxetan from two scans to a single scan
alefacept Biogen BL 125036 44 S 11/1/2004 9/1/2005 10.0 Revise the Warnings and Precautions sections to recommend reducing monitoring of CD4T+ lymphocytes to every two weeks, to add a new Contraindication regarding use in patients with HIV, and to update the Geriatric Use, Adverse Reaction and Dosage and Administration sections of the package insert (narrowed indication)
infliximab Centocor BL 103772 5113 P 3/24/2005 9/15/2005 5.7 New indication for the treatment of patients with moderately to severely active ulcerative colitis (UC), who have had an inadequate response to conventional therapy
pegfilgrastim Amgen BL 125031 52 S 11/15/2004 9/15/2005 10.0 Revise the Clinical Studies section of the package insert to include results of a study conducted in patients with a lower incidence of febrile neutropenia than the original
registration studies and to update the Geriatric Use subsection and the Adverse Reactions section
bevacizumab Genentech BL 125085 45 S 5/24/2005 9/29/2005 4.2 Revise the Clinical Studies section of the package insert to include the results of the NCI's Treatment Referral Center (TRC) study of Bevacizumab, infusional 5-
fluorouracil, and leucovorin
adalimumab Abbott BL 125057 45 S 12/16/2004 10/3/2005 9.6 Expand the indication to include psoriatic arthritis
adalimumab Abbott BL 125057 46 S 12/16/2004 10/3/2005 9.5 Expand the indication to include recently diagnosed patients with moderately to severely active rheumatoid arthritis who have not received methotrexate
epoetin alfa Amgen BL 103234 5082 S 12/27/2004 10/27/2005 10.0 Add a Pediatric Cancer Patients on Chemotherapy subsection to the Clinical Experience section of the package insert and to revise the Pediatric Cancer Patients on Chemotherapy subsection of the Precautions section and the Dosage and Administration section of the package insert
darbepoetin alfa Amgen BL 103951 5088 S 2/16/2005 12/15/2005 10.0 Modify the product label to incorporate pediatric pharmacokinetic data and the results of a clinical study that examined the safety and efficacy of darbepoetin alfa among pediatric patients with chronic renal failure (CRF) who were transitioned from treatment with epoetin alfa to darbepoetin alfa

Review Class:  
P -   Priority Review - Significant improvement compared to marketed products, in the treatment, diagnosis, or prevention of a disease.
S -   Standard Review - Products that do not qualify for priority review.
O -  Orphan Designation - Pursuant to Section 526 of the Orphan Drug Act (Public Law 97-414 as amended).

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 12/31/05

 

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Date updated: October 13, 2006
horizonal rule

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