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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