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Efficacy Supplement Approvals in 2005

NDA Efficacy Supplements   N & SE1 -SE7         SE8        BLA Efficacy Supplements

 

NDA Efficacy Supplements Approved (N, SE1-SE7)         

Established Name

ApplicantNDA NumberSupp TypeSupp NumberReview ClassReceipt DateApproval DateTotal Approval Time (Months)Indication / Description
ciprofloxacinBayer020780SE7016S3/8/20041/7/200510.0Provides 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
ciprofloxacinBayer019857SE7035S3/8/20041/7/200510.0Provides 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
ciprofloxacinBayer019847SE7030S3/8/20041/7/200510.0Provides 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 hydrochlorideBayer019537SE7052S3/8/20041/7/200510.0Provides 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 estradiolWarner Chilcott021065SE2012S3/15/20041/14/200510.0Provides 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 hydrochlorideAlza050718SE7020S3/29/20041/28/200510.0Provides for the use of Doxil® for the treatment of patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy.
fentanylAlza019813SE2039S4/6/20042/4/200510.0Provides 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 succinateAstraZeneca019962SE2027S4/30/20042/15/20059.6Provides 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 cilexetilAstraZeneca020838SE1024P6/30/20042/22/20057.8Provides 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.
ribavirinRoche021511SE1005P8/26/20042/25/20056.0Provides 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).
rosiglitazoneGlaxoSmithKline021071SE1012S4/30/20042/28/200510.0Provides 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).
aripiprazoleOtsuka021436SE1005S1/30/20043/1/200513.0

Provides for the use of Abilify® Tablets as maintenance therapy in Bipolar I Disorder

aripiprazoleOtsuka021713SE1003S2/16/20053/1/20050.4

Provides for the use of Abilify® Oral Solution as maintenance therapy in Bipolar I Disorder

sirolimusWyeth021083SE5019P9/13/20043/11/20055.9

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).

sirolimusWyeth021110SE5024P9/13/20043/11/20055.9Provides 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).
temozolomideSchering021029SE1008P, O9/15/20043/15/20056.0

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 sodiumFujisawa Healthcare021754N000S4/26/20043/16/200510.7

Provides for the use of Mycamine™ (micafungin sodium) for Injection, for the treatment of esophageal candidiasis.

ibandronate sodiumRoche021455SE2001S5/25/20043/24/200510.0

Provides for once-monthly treatment of postmenopausal osteoporosis with Boniva (ibandronate sodium) 150 mg Tablets.

bortezomibMillennium021602SE1006P, O9/28/20043/25/20055.9

Provides for the use of Velcade (bortezomib) for Injection for treatment of multiple myeloma patients who have received as least one prior therapy.

ondansetronGlaxoSmithKline020007SE5035P9/29/20043/25/20055.8Provides for updating the label with new pediatric information.
budesonideAstraZeneca021324SE1005S7/1/20044/29/20059.9Provides 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; ritonavirAbbott021226SE2016S7/1/20044/29/20059.9Provides for the use of Kaletra 800/200mg once-daily administration for the treatment of HIV- infection in therapy-naïve adult patients.
carvedilolGlaxoSmithKline020297SE1013S1/20/20044/29/200515.3Provides 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 hydrochlorideGlaxoSmithKline020658SE1013P7/7/20035/4/200522.1Provides for the use of Requip (ropinirole HCl) Tablets for Restless Legs Syndrome (RLS).
azelaic acidBerlex021470SE1003S12/18/20035/5/200516.6Provides for a qualified reduction of erythema during the topical treatment of inflammatory papules and pustules of mild to moderate rosacea.
abacavir sulfate; lamivudine; zidovudineGlaxoSmithKline021205SE7011S7/16/20045/13/20059.9Provides for the use of Trizivir Tablets in combination with other antiretroviral agents or alone for the treatment of HIV-1 infection.
ethinyl estradiol; norgestimateOrtho-McNeil021690N000P11/19/20045/13/200519.6Provides 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 sodiumMerck021337SE1018P11/22/20045/18/20055.8Provides for the use of Invanz (ertapenem for injection) in the pediatric population.
candesartan cilexetilAstraZeneca020838SE1022P3/18/20055/18/200510.6Provides 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-131Draximage021305SE1003S7/19/20045/19/200510.0Provides 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.
meropenemAstraZeneca050706SE1018S7/28/20045/25/20059.9Provides 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 sodiumGlaxoSmithKline021345SE1010S7/30/20045/26/20059.9Provides for the use of Arixtra (fondaparinux sodium, injection) in patients undergoing abdominal surgery who are at risk for thromboembolic complications.
pregabalinPfizer021724N000S10/31/20036/10/200519.3Provides 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 hydrochlorideBayer021277SE1022S8/13/20046/13/200510.0Provides 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 hydrochlorideBayer021085SE1026S8/13/20046/13/200510.0Provides 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.
bivalirudinMedicines Company020873SE1006S7/28/20036/13/200522.6Provides 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).
capecitabineHoffmann-La Roche020896SE1016S8/18/20046/15/20059.9Provides 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.
nitazoxanideRomark021818N000P5/29/20026/16/200536.6Provides 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.
nitazoxanideRomark021498SE5003P12/20/20046/16/20055.9Provides 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 sucroseLuitpold021135SE1008S8/18/20036/17/200522.0Provides 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.
levetiracetamUCB021505SE5007P12/21/20046/21/20056.0Provides 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.
levetiracetamUCB021035SE5040P12/21/20046/21/20056.0Provides 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.
somatropinGenentech019676SE1020S12/22/20036/28/200518.2Provides for the long-term treatment of idiopathic short stature.
somatropinGenentech020522SE1021S2/2/20046/28/200516.8Provides for the long-term treatment of idiopathic short stature.
topiramateOrtho-McNeil020505SE1018S10/30/20026/29/200532.0Provides 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.
topiramateOrtho-McNeil020844SE1015S10/30/20026/29/200532.0Provides 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 amphetamineShire021303SE5009P9/17/20047/21/200510.1Provides for the use of Adderall XR in the treatment of adolescents with attention-deficit hyperactivity disorder.
montelukast sodiumMerck021409SE1012S9/30/20047/27/20059.9Provides 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 sodiumMerck020830SE1035S9/30/20047/27/20059.9Provides 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 sodiumMerck020829SE1033S9/30/20047/27/20059.9Provides 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.
rosiglitazoneGlaxoSmithKline021071SE5015P9/30/20047/29/20059.9

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.

celecoxibPfizer020998SE1018S10/1/20047/29/20059.9Provides for the use of Celebrex® (celecoxib) capsules for the relief of signs and symptoms of ankylosing spondylitis.
valsartanNovartis021283SE1011S12/17/20038/3/200519.6Provides 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.
levofloxacinOrtho McNeil021721SE2002S11/2/20048/4/20059.0Provides for the use of Levaquin® (levofloxacin) 750 mg Oral Solution once daily for five days for the treatment of acute bacterial sinusitis.
levofloxacinOrtho McNeil020635SE2038S11/2/20048/4/20059.0Provides for the use of Levaquin® (levofloxacin or levofloxacin in 5% dextrose) Injection once daily for five days for the treatment of acute bacterial sinusitis.
levofloxacinOrtho McNeil020634SE2037S11/2/20048/4/20059.0Provides for the use of Levaquin® (levofloxacin) Tablets once daily for five days for the treatment of acute bacterial sinusitis.
meloxicamBoehringer Ingelheim021530SE1001P, O2/18/20058/11/20055.7Provides 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.
meloxicamBoehringer Ingelheim020938SE1013P, O2/18/20058/11/20055.7Provides 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 F18North Shore/LIJ Research Institute021870N000S11/19/20048/19/20059.0Provides 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 erbumineSolvay020184SE1011P12/10/20048/23/20058.4Provides 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.
iloprostCoTherix021779SE1001S4/27/20058/24/20053.9Provides 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 aspartNovo Nordisk020986SE5033P3/15/20059/13/20056.0

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.

anastrozoleAstraZeneca020541SE7016S11/18/20049/16/20059.9

Provides the updated report of the ATAC data as requested in a subpart H commitment associated with the approval of supplemental application 010.

atorvastatin calciumPfizer020702SE1042S12/20/20049/21/20059.0

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 besylatePfizer019787SE1038S4/1/20059/28/20055.9Proposes changes to the package insert for the use of Norvasc (amlodipine besylate) Tablets in patients with angiographically documented coronary artery disease.
exemestanePfizer020753SE1006S12/9/200410/5/20059.9Provides 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.
ritonavirAbbott020659SE5034P4/7/200510/6/20056.0Provides 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.
ritonavirAbbott020945SE5017P4/7/200510/6/20056.0Provides 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 hydrochlorideAventis020872SE2015S12/14/200410/13/200510.0Provides for Allegra (fexofenadine) 180 mg tablets used once daily in chronic idiopathic urticiaria (CIU).
ertapenem sodiumMerck021337SE1019S12/17/200410/14/20059.9Provides for the use of INVANZ® (ertapenem sodium) in the treatment of adult diabetic foot infections without osteomyelitis.
iron sucroseLuitpold021135SE1013S12/17/200410/17/200510.0Provides 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 Nordisk021878N000S12/20/200410/19/200510.0Provides for the use of Levemir (insulin detemir) in pediatric patients with type 1 diabetes.
losartan potassium; hydrochlorothiazideMerck020387SE2037S12/20/200410/20/200510.0Provides for registration of a losartan 100 mg and hydrochlorothiazide
12.5 mg fixed-dose combination tablet.
insulin (rDNA origin)Novo Nordisk019938SE3048S12/23/200410/21/20059.9Provides 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 aspartNovo Nordisk020986SE3032S12/23/200410/21/20059.9Provides 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.
oxcarbazepineNovartis021285SE5008P12/14/200410/28/200510.5Provides 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.
oxcarbazepineNovartis021014SE5013P12/14/200410/28/200510.5Provides 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.
aprepitantMerck021549SE1008S9/29/200410/28/200513.0Provides 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 hydrochlorideOSI021743SE1003P5/2/200511/2/20056.0Provides 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 acetonideHill Dermac021930N000P5/9/200511/9/20056.0Provides for the use of fluocinolone acetonide oil, 0.01% ear drops for
treatment of chronic eczematous external otitis.
venlafaxine hydrochlorideWyeth020699SE1054S9/29/200411/18/200513.6Provides for the use of Effexor XR in the treatment of short-term panic disorder.
venlafaxine hydrochlorideWyeth020699SE1057S9/29/200411/18/200513.6Provides for the use of Effexor XR in the treatment of long-term panic disorder.
sodium oxybateOrphan Medical021196SE1005S1/18/200511/18/200510.0Provides for the use of Xyrem ® (sodium oxybate) oral solution for the treatment of excessive daytime sleepiness in patients with narcolepsy.
moxifloxacin hydrochlorideBayer021085SE1027S2/1/200511/22/20059.7Provides 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 hydrochlorideBayer021277SE1024S1/31/200511/22/20059.7Provides 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.
glimepirideAventis020496SE5015P3/15/200511/28/20058.5Provides 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
bivalirudinMedicines Company020873SE1011S1/31/200511/30/200510.0Provides for the use of Angiomax® (bivalirudin) for Injection for patients with, or at risk of, HIT/HITTS undergoing PCI.
venlafaxine hydrochlorideWyeth020699SE5059S12/2/200412/1/200512.0Provides for additional safety data for changes in weight, height, and appetite occurring in pediatric patients with social anxiety disorder treated with Effexor XR.
divalproex sodiumAbbott021168SE1012S10/26/200412/6/200513.3Proposes 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 hydrocholorideAbbott020632SE5021P6/22/200412/8/200517.6Provides for labeling changes to the Meridia (sibutramine hydrochloride monohydrate) Capsules Package Insert (PI).
oseltamivir phosphateRoche021087SE5030S4/18/200512/21/20058.1Provides for the use of Tamiflu (oseltamivir phosphate) Capsules for prophylaxis of influenza for patients between 1-12 years of age.
oseltamivir phosphateRoche021246SE5017S4/18/200512/21/20058.1Provides for the use of Tamiflu (oseltamivir phosphate) Oral Suspension for prophylaxis of influenza for patients between 1-12 years of age.
alendronate sodiumMerck020560SE1038P11/3/200412/21/200534.7Provides 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; levonorgestrelBerlex021885N000S3/1/200512/27/20059.9Provides for the use of Climara Pro (estradiol/levonorgestrel) Transdermal
System for the prevention of postmenopausal osteoporosis.
letrozoleNovartis020726SE1012P6/28/200512/28/20056.0Provides 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 NameApplicantNDA NumberSupp TypeSupp NumberReview
Class
Receipt DateApproval DateTotal Approval Time (Months)
alosetron hydrochloride

GlaxoSmithKline

021107SE8009S3/31/20041/31/200510.0
telithromycinAventis021144SE8001S4/9/20042/9/200510.0
caspofungin acetateMerck021227SE8015S4/16/20042/16/200510.0
epirubicin hydrochloridePfizer050778SE8008S5/3/20043/2/200510.0
imatinib mesylateNovartis021588SE8005S9/8/20043/14/20056.1
hydrochlorothiazide; losartan potassiumMerck020387SE8033S7/8/20044/5/20058.9
lovastatinMerck019643SE8075S7/1/20044/7/20059.2
gemcitabine hydrochlorideLilly020509SE8033P10/27/20044/26/20056.0
linezolidPharmacia & Upjohn021130SE8009P12/17/20045/12/20054.8
linezolidPharmacia & Upjohn021131SE8010P12/17/20045/12/20054.8
linezolidPharmacia & Upjohn021132SE8010P12/17/20045/12/20054.8
tenofovir disoproxil fumarateGilead021356SE8011S7/13/20045/12/200510.0
atomoxetine hydrochlorideLilly021411SE8008S7/29/20045/26/20059.9
amoxicllin; clavulanate potassiumGlaxoSmithKline050785SE8006S5/17/20046/15/200513.0
oxandroloneSavient013718SE8023S8/26/20026/20/200533.8
budesonideAstraZeneca020929SE8022S9/2/20046/30/20059.9
etonogestrel; ethinyl estradiolOrganon021187SE8012S9/30/20047/29/20059.9
testosteroneUnimed021015SE8011S7/1/20048/11/200513.3
intrauterine copperFEI018680SE8060S11/3/20049/1/20059.9
somatropin, biosyntheticLilly019640SE8045S12/15/200410/12/20059.9
imatinib mesylateNovartis021588SE8008S12/23/200410/20/20059.9
tolterodinePharmacia & Upjohn021228SE8007S12/22/200410/20/20059.9
fenofibrateReliant021695SE8001S12/23/200410/21/20059.9
fluocinolone acetonideHill Dermac019452SE8019S4/2/200311/9/200531.3
fluocinolone acetonideHill Dermac019452SE8020S4/2/200311/9/200531.3
somatropin (rDNA origin)Genentech020522SE8027S1/24/200511/18/20059.8
insulin aspartNovo Nordisk021172SE8021S1/21/200511/21/200510.0
bosentanActelion021290SE8006S3/21/200511/29/20058.3
montelukast sodiumMerck021409SE8014S1/31/200511/30/200510.0
montelukast sodiumMerck020830SE8036S1/31/200511/30/200510.0
montelukast sodiumMerck020829SE8034S1/31/200511/30/200510.0
  BLA Efficacy Supplements Approved
Proper NameApplicantBLA NumberSupp NumberPriority ReviewReceipt DateApproval DateTotal Approval Time (MonthsIndication/Description
alteplaseGenentechBL1031725071.0S5/4/20041/4/20058.0

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-2aHoffmann-La RocheBL 1039645039P8/30/20042/25/20055.8Expanded 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
infliximabCentocorBL 1037725089S7/30/20045/13/20059.5Expands the indication to include treatment of psoriatic arthritis
peginterferon alfa-2aHoffmann-La RocheBL 1039645037S7/13/20045/13/200510.0Treatment 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
becaplerminOMJBL 1036915015S5/2/20035/13/200524.4Revises 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
etanerceptImmunexBL 1037955191S8/30/20045/27/20058.9Revises 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 tiuxetanBiogenBL 12501988S9/27/20047/27/200510.0Revise 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
alefaceptBiogenBL 12503644S11/1/20049/1/200510.0Revise 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)
infliximabCentocorBL 1037725113P3/24/20059/15/20055.7New indication for the treatment of patients with moderately to severely active ulcerative colitis (UC), who have had an inadequate response to conventional therapy
pegfilgrastimAmgenBL 12503152S11/15/20049/15/200510.0Revise 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
bevacizumabGenentechBL 12508545S5/24/20059/29/20054.2Revise 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
adalimumabAbbottBL 12505745S12/16/200410/3/20059.6Expand the indication to include psoriatic arthritis
adalimumabAbbottBL 12505746S12/16/200410/3/20059.5Expand the indication to include recently diagnosed patients with moderately to severely active rheumatoid arthritis who have not received methotrexate
epoetin alfaAmgenBL 1032345082S12/27/200410/27/200510.0Add 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 alfaAmgenBL 1039515088S2/16/200512/15/200510.0Modify 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 TypeDescription
NType 6 NDA - New indication
SE1New or modified indication
SE2New dosage regimen
SE3New route of administration
SE4Comparative efficacy claim
SE5Patient population altered
SE6Change the marketing status from prescription to over-the-counter use
SE7Complete the traditional approval of a product originally approved under subpart H (accelerated approval)
SE8Incorporate other information based on at least one adequate and well-controlled clinical study

Updated quarterly through 12/31/05