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Efficacy Supplement Approvals in 2004

   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

amlodipine besylate Pfizer 019787 SE5 030   9/17/01 1/8/04 27.7 Provides for changes in the CLINICAL PHARMACOLOGY, INDICATIONS AND USAGE, PRECAUTIONS, and DOSAGE AND ADMINISTRATION sections of the labeling concerning use of Norvasc (amlodipine besylate) 2.5 mg to 5 mg tablets in pediatric patients with hypertension
oxaliplatin Sanofi 021492 SE1 002 Y 7/11/03 1/9/04 6.0 Provides for the use of Eloxatin in combination with infusional 5-Fluorouracil (5-FU) and Leucovorin (LV) for the treatment of patients previously untreated for advanced colorectal cancer
quetiapine fumarate AstraZeneca 020639 SE1 016   12/30/02 1/12/04 12.4 Provides for the use of Seroquel (quetiapine fumarate) tablets as monotherapy in the treatment of acute manic episodes associated with Bipolar I disorder
quetiapine fumarate AstraZeneca 020639 SE1 017   12/30/02 1/12/04 12.4 Provides for the use of Seroquel (quetiapine fumarate) tablets as adjunctive therapy with mood stabilizers (lithium or divalproex) in the treatment of acute manic episodes associated with Bipolar I disorder
olanzapine Lilly 020592 SE1 019   11/21/02 1/14/04 13.8 Provides for the use of olanzapine in the long-term treatment of bipolar I disorder
azithromycin Pfizer 050784 SE1 004   3/17/03 1/15/04 10.0 Provides for treatment of acute bacterial sinusitis using a 3-day regimen of Zithromax (azithromycin) Tablets 
modafinil Cephalon 020717 SE1 008   12/20/02 1/23/04 13.1 Provides for the use of Provigil (modafinil) Tablets to improve wakefulness in two new patient populations with excessive sleepiness:  those with obstructive sleep apnea/hypopnea syndrome and those with shift work sleep disorder
paroxetine hydrochloride GlaxoSmithKline 020936 SE2 013   3/27/03 1/27/04 10.1 Provides for the use of Paxil CR in the treatment of premenstrual dysphoric disorder (PMDD) using an intermittent dosing regimen
synthetic conjugated estrogens A Duramed 020992 SE2 021   8/2/02 2/5/04 18.1 Provides for the use of Cenestin (synthetic conjugated estrogens A) 0.45 mg tablets for the treatment of moderate to severe vasomotor symptoms associated with the menopause
benazepril hydrochloride Novartis 019851 SE5 028 Y 4/25/03 3/2/04 10.3 Proposes changes in the DESCRIPTION, CLINICAL PHARMACOLOGY, PRECAUTIONS, ADVERSE REACTIONS, and DOSAGE AND ADMINISTRATION sections of the labeling concerning the use of Lotensin (benazepril HCl) 5, 10, 20 and 40 mg Tablets in pediatric patients with hypertension
imiquimod 3M 020723 SE1 015   5/2/03 3/2/04 10.0 Provides for the use of Aldara (imiquimod) Cream, 5% for the topical treatment of clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses on the face or scalp in immunocompetent adults.
leflunomide Aventis Pharms 020905 SE5 012 Y 9/5/03 3/5/04 6.0 Provides for additional language to the CLINICAL PHARMACOLOGY, CLINICAL STUDIES and ADVERSE REACTIONS sections of the label
remifentanil hydrochloride Abbott 020630 SE5 005   1/6/00 3/8/04 50.1 Provides for revised labeling to include description of a clinical study of Ultiva vs Halothane in neonates and infants undergoing surgery for Pyloric Stenosis, extension of safety and efficacy of Ultiva as an analgesic agent for use in the maintenance of general anesthesia in outpatient surgery down to the age of "birth," and extension of the doses for pediatric patients for maintenance of general anesthesia down to the age of "birth."
losartan potassium Merck 020386 SE5 029   12/21/01 3/11/04 26.7 Provides for pediatric-related changes to the CLINICAL PHARMACOLOGY, PRECAUTIONS, ADVERSE REACTIONS, and DOSAGE AND ADMINISTRATION sections of the labeling.  In addition, there are other minor revisions to the DESCRIPTION and CLINICAL PHARMACOLOGY sections of the labeling
glyburide and metformin hydrochloride Bristol Myers Squibb 021178 SE5 007 Y 7/21/03 3/15/04 7.8 Provides for labeling changes to the CLINICAL PHARMACOLOGY section, Pediatric subsection, PRECAUTIONS section, Pediatric Use subsection, OVERDOSAGE section, metformin hydrochloride subsection, and DOSAGE AND ADMINISTRATION section Specific Patient Populations subsection of the package insert
nelfinavir mesylate Agouron 020778 SE5 022 Y 6/20/03 3/19/04 9.0 Provides for the use of Viracept (nelfinavir mesylate) oral powder in combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients from two to thirteen years of age
nelfinavir mesylate Agouron 020779 SE5 042 Y 6/20/03 3/19/04 9.0 Provides for the use of Viracept (nelfinavir mesylate) tablets in combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients from two to thirteen years of age
nelfinavir mesylate Agouron 021503 SE5 001 Y 6/20/03 3/19/04 9.0 Provides for the use of Viracept (nelfinavir mesylate) tablets in combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients from two to thirteen years of age
ciprofloxacin Bayer Pharms 019537 SE5 049 Y 9/25/03 3/25/04 6.0 Provides for the use of Cipro (ciprofloxacin) for the treatment of complicated urinary tract infections and pyelonephritis for pediatric patients (1 to 17 years of age) with updated information to be included in the INDICATIONS AND USAGE section of the final printed labeling
ciprofloxacin  Bayer Pharms 019847 SE5 027 Y 9/29/03 3/25/04 5.9 Provides for the use of Cipro (ciprofloxacin) for the treatment of complicated urinary tract infections and pyelonephritis for pediatric patients (1 to 17 years of age) with updated information to be included in the INDICATIONS AND USAGE section of the final printed labeling
ciprofloxacin  Bayer Pharms 019857 SE5 031 Y 9/29/03 3/25/04 5.9 Provides for the use of Cipro (ciprofloxacin) for the treatment of complicated urinary tract infections and pyelonephritis for pediatric patients (1 to 17 years of age) with updated information to be included in the INDICATIONS AND USAGE section of the final printed labeling
ciprofloxacin  Bayer Pharms 020780 SE5 013 Y 9/29/03 3/25/04 5.9 Provides for the use of Cipro (ciprofloxacin) for the treatment of complicated urinary tract infections and pyelonephritis for pediatric patients (1 to 17 years of age) with updated information to be included in the INDICATIONS AND USAGE section of the final printed labeling
rofecoxib Merck 021647 N 000   5/27/03 3/26/04 10.0 Provides for the use of Vioxx (rofecoxib) for the acute treatment of migraine in adults
paricalcitol Abbott 020819 SE5 014 Y 9/30/03 3/31/04 6.0 Provides for the use of Zemplar (paricalcitol) Injection in pediatric patients with Stage 5 chronic kidney disease (end-stage renal disease)
fenoldopam mesylate Abbott 019922 SE5 005 Y 10/1/03 4/1/04 6.0 Provides for the use of Corlopam (fenoldopam mesylate) 10mg/mL Injection for the in-hospital, short-term (up to 4 hours) reduction in blood pressure in pediatric patients.
diltiazem hydrochloride Biovail 021392 SE1 002   6/9/03 4/2/04 9.8 Provides for the use of Cardizem LA (diltiazem hydrochloride) 120, 180, 240, 300, 360 and 420 mg for the management of chronic stable angina
abacavir sulfate GlaxoSmithKline 020978 SE7 013   6/16/03 4/15/04 10.0 Provides for the use of Ziagen® (abacavir sulfate) tablets and oral solution in combination with other antiretroviral agents for the treatment of HIV-1 infection.  This supplemental application provides information to fulfill the accelerated approval commitments as required under CFR 314.510.
abacavir sulfate GlaxoSmithKline 020977 SE7 011   6/16/03 4/15/04 10.0 Provides for the use of Ziagen® (abacavir sulfate) tablets and oral solution in combination with other antiretroviral agents for the treatment of HIV-1 infection.  This supplemental application provides information to fulfill the accelerated approval commitments as required under CFR 314.510.
dorzolamide hydrochloride Merck 020408 SE5 033 Y 10/17/03 4/15/04 6.0 Provides for revisions in the label to reflect the safe and effective use of Trusopt (dorzolamide hydrochloride ophthalmic solution) 2% in pediatric patients with elevated intraocular pressure.
salmeterol; fluticasone propionate  GlaxoSmithKline 021077 SE5 017   6/27/03 4/21/04 9.8 Provides for the use of Advair Diskus 100/50 mcg in children 4 to 11 years of age with asthma.
doxercalciferol Bone Care 020862 SE1 006   12/27/01 4/23/04 27.9 Proposes the use of a new, lower strength of Hectorol Capsules, (0.5 ug), for the management of secondary hyperparathyroidism in patients with moderate to severe chronic renal insufficiency not yet on dialysis.
guaifenesin; dextromethorphan  Adams Labs 021620 N 000   6/30/03 4/29/04 10.0 Provides for the use of Mucinex™DM (guaifenesin and dextromethorphan HBr) Extended-release Tablets as an expectorant and antitussive.
venlafaxine hydrochloride Wyeth Pharms 020151 SE5 024 Y 9/26/02 5/5/04 19.3 Provides for additional safety data in the pediatric population for Effexor (venlafaxine hydrochloride) Immediate Release Tablets.
venlafaxine hydrochloride Wyeth Pharms 020699 SE5 030 Y 9/26/02 5/5/04 19.3 Provides for additional safety data in the pediatric population for Effexor XR (venlafaxine hydrochloride) Extended Release Capsules.
tinidazole Presutti Labs 021681 N 000   7/17/03 5/17/04 10.0 Provide for the use of Tindamax™ (tinidazole tablets) for the treatment of giardiasis.
tinidazole Presutti Labs 021682 N 000   7/17/03 5/17/04 10.0 Provide for the use of Tindamax™ (tinidazole tablets) for the treatment of amebiasis and amebic liver abscess.
moxifloxacin hydrochloride Bayer Pharms 021277 SE1 017 Y 2/18/04 5/18/04 3.0 Provides for the use of Avelox® I.V. for the treatment of Community Acquired Pneumonia caused by multi-drug resistant Streptococcus pneumoniae. 
moxifloxacin hydrochloride Bayer Pharms 021085 SE1 022 Y 2/18/04 5/18/04 3.0 Provides for the use of Avelox® tablets for the treatment of Community Acquired Pneumonia caused by multi-drug resistant Streptococcus pneumoniae. 
docetaxel Aventis Pharms 020449 SE1 028 Y 1/27/04 5/19/04 3.7 Provides for the use of Taxotere® (docetaxel) in combination with prednisone as a treatment for patients with androgen independent (hormone refractory) metastatic prostate cancer.
gemcitabine hydrochloride Lilly 020509 SE1 029 Y 12/18/03 5/19/04 5.0 Provides for the use of Gemzar® (gemcitabine HCl) for Injection in combination with paclitaxel for the first-line treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated.
epinephrine Hollister Stier Labs 020800 SE5 001   7/28/03 5/28/04 10.0 Indicated for the emergency treatment of severe allergic reactions, including anaphylaxis in patients who weigh 15-30 kg (approximately 33-66 Lbs).
fondaparinux sodium Fonda Bv 021345 SE1 005   7/31/03 5/28/04 9.9 Provides for the use of Arixtra (fondaparinux sodium) Injection for the treatment of acute pulmonary embolism when administered in conjunction with warfarin sodium.
fondaparinux sodium Fonda Bv 021345 SE1 004   7/31/03 5/28/04 9.9 Provides for the use of Arixtra (fondaparinux sodium) Injection for the treatment of acute deep vein thrombosis without pulmonary embolism when administered in conjunction with warfarin sodium.
lispro insulin Lilly 020563 SE3 024   12/21/99 6/2/04 53.4 Provides for the use of Humalog with the following external insulin pumps:  1. MiniMed Models 506, 507, and 508 using MiniMed Polyfin infusion sets, or  2. Disertronic H-TRONplus V100 insulin pump (with plastic 3.15 mL insulin reservoir), and the Disertronic D-TRON and D-TRON plus insulin pumps (with Humalog 3 mL cartridges) using Disertronic Rapid infusion sets.
estradiol transdermal Berlex Labs 021674 N 000   8/8/03 6/8/04 10.0 Provides for the use of Menostar (estradiol transdermal system) for prevention of postmenopausal osteoporosis.
lansoprazole Tap Pharm 020406 SE5 057 Y 12/23/03 6/17/04 5.8 Provides for the use of lansoprazole for the treatment of symptomatic GERD, nonerosive esophagitis and erosive esopagitis in pediatric patients between 12 and 17 years of age.
levothyroxine sodium Stevens J 021210 SE4 002   3/27/03 6/23/04 14.9 Establishes Unithroid (levothyroxine sodium tablets, USP) 25, 50, 75, 88, 100, 112, 125, 150, 175, 200, and 300 mcg tablets to be bioequivalent and therapeutically equivalent to the listed drug Levoxyl (levothyroxine sodium tablets, USP) 25, 50, 75, 88, 100, 112, 125, 150, 175, 200, and 300 mcg tablets.
levothyroxine sodium Alara Pharm 021342 SE4 004   6/12/03 6/23/04 12.4 Establishes Levo-T (levothyroxine sodium tablets, USP) 25, 50, 75, 88, 100, 112, 125, 137, 150, 175, 200, and 300 mcg tablets to be bioequivalent and therapeutically equivalent to the listed drug Synthroid (levothyroxine sodium tablets, USP) 25, 50, 75, 88, 100, 112, 125, 137, 150, 175, 200,and 300 mcg tablets.
levothyroxine sodium Alara Pharm 021342 SE4 003   4/2/03 6/23/04 14.7 Establishes Levo-T (levothyroxine sodium tablets, USP) 25, 50, 75, 88, 100, 112, 125, 137, 150, 175, 200, and 300 mcg tablets to be bioequivalent and therapeutically equivalent to the listed drug Levoxyl (levothyroxine sodium tablets, USP) 25, 50, 75, 88, 100, 112, 125, 137, 150, 175, 200,
and 300 mcg tablets.
linezolid Pharmacia And Upjohn 021131 SE5 007 Y 12/23/03 6/23/04 6.0 Provides for the use of Zyvox™ IV Injection for the treatment of:  1. Community Acquired Pneumonia caused by S. pneumoniae (including multi-drug resistant strains, [MDRSP])  2. Nosocomial Pneumonia caused by S. pneumoniae (including multi-drug resistant strains, [MDRSP]).
linezolid Pharmacia And Upjohn 021132 SE5 006 Y 12/23/03 6/23/04 6.0 Provides for the use of Zyvox™ Oral Suspension for the treatment of:  1. Community Acquired Pneumonia caused by S. pneumoniae (including multi-drug resistant strains, [MDRSP])  2. Nosocomial Pneumonia caused by S. pneumoniae (including multi-drug resistant strains, [MDRSP]).
linezolid Pharmacia And Upjohn 021130 SE5 006 Y 12/23/03 6/23/04 6.0 Provides for the use of Zyvox™ Tablets for the treatment of:  1. Community Acquired Pneumonia caused by S. pneumoniae (including multi-drug resistant strains, [MDRSP])  2. Nosocomial Pneumonia caused by S. pneumoniae (including multi-drug resistant strains, [MDRSP]).
gatifloxacin Bristol Myers Squibb 021061 SE1 022 Y 12/30/03 6/30/04 6.0 Provides for the use of Tequin® (gatifloxacin) Tablets for the treatment of Community Acquired Pneumonia caused by multi-drug resistant Streptococcus pneumoniae.
gatifloxacin Bristol Myers Squibb 021062 SE1 023 Y 12/30/03 6/30/04 6.0 Provides for the use of Tequin® (gatifloxacin) Injection and Tequin® (gatifloxacin in 5% Dextrose) Injection for the treatment of Community Acquired Pneumonia caused by multi-drug resistant Streptococcus pneumoniae.
atazanavir sulfate Bristol Myers Squibb 021567 SE2 002   10/31/03 7/6/04 8.2 Provides for a new dosing regimen of Reyataz® (atazanavir) 300mg/ritonavir 100mg once daily for treatment in HIV-infected antiretroviral-experienced patients.
levofloxacin Ortho McNeil Pharm 020634 SE1 030 Y 3/3/04 7/14/04 4.4 Provides for the use of Levaquin® (levofloxacin) Tablets for the treatment of Community Acquired Pneumonia caused by Multi-Drug Resistant Streptococcus pneumoniae.
levofloxacin Ortho McNeil Pharm 020635 SE1 030 Y 3/3/04 7/14/04 4.4 Provides for the use of Levaquin® (levofloxacin) Injection and Levaquin® (levofloxacin in 5% dextrose) Injection for the treatment of Community Acquired Pneumonia caused by Multi-Drug Resistant Streptococcus pneumoniae.
imiquimod 3M 020723 SE1 016   6/10/03 7/14/04 13.2 Provides for the use of Aldara (imiquimod) Cream, 5% for the topical treatment of biopsy-confirmed, primary superficial basal cell carcinoma (sBCC) in immunocompetent adults, with a maximum tumor diameter of 2.0 cm, located on the trunk (excluding anogenital skin), neck, or extremities (excluding hands and feet), only when surgical methods are medically less appropriate and patient follow-up can be reasonably assured.
meloxicam Boehringer Ingelheim 020938 SE1 004   2/28/01 7/16/04 40.6 Provides for the use of Mobic® (meloxicam) Tablets, 7.5 mg and 15 mg for the relief of the signs and symptoms of rheumatoid arthritis in adults.
nitazoxanide Romark 021498 SE1 002   7/19/04 7/21/04 0.1 Provides for the use of Alinia® (nitazoxanide) Oral Suspension 100 mg/5mL for the treatment of diarrhea caused by Giardia lamblia in patients 12 years of age and older.
ursodiol Axcan Scandipharm 020675 SE2 009   9/22/03 7/21/04 10.0 Provides for the addition of a new name and strength, Tradename™ (ursodiol) Tablets 500 mg, and a change in dosage regimen of 2 to 4 times daily.
thallous chloride T1-201 Mallinckrodt 018150 SE1 019   9/30/03 7/23/04 9.8 Provides for the use of Thallous Chloride T1-201 scintigraphic imaging of the myocardium to identify changes in perfusion induced by pharmacologic stress in patients with known or suspected coronary artery disease and who cannot exercise adequately.
loratadine; pseudoephedrine sulfate Schering 019670 SE1 019   3/10/04 7/30/04 4.7 Provides for the use of Claritin-D 12 Hour (loratadine 5 mg and pseudoephedrine 120 mg) Extended Release Tablets in the temporary relief of nasal congestion due to the common cold in adults and children 12 years and older.
loratadine; pseudoephedrine sulfate Schering 020470 SE1 022   3/10/04 7/30/04 4.7 Provides for the use of Claritin-D 24 Hour (loratadine 10 mg and pseudoephedrine 240 mg) Extended Release Tablets in the temporary relief of nasal congestion due to the common cold in adults and children 12 years and older.
atorvastatin calcium Pfizer 020702 SE1 039   10/1/03 7/30/04 10.0 Provides for the use of atorvastatin in adult patients without clinically evident coronary heart disease (but with multiple risk factors for coronary heart disease such as age ≥ 55 years, smoking, hypertension, low HDL-C or a family history of early coronary heart disease), to reduce the risk of myocardial infarction, and to reduce the risk for revascularization procedures and angina. Also provides for changes to the CLINICAL PHARMACOLOGY, INDICATIONS AND USAGE and ADVERSE EVENTS sections of the labeling.
abacavir sulfate GlaxoSmithKline 020978 SE2 014   10/3/03 8/2/04 10.0 Provides for the use of Ziagen (abacavir sulfate, 600 mg) oral solution once daily in combination with other antiretroviral agents for the treatment of HIV-1 infection.
abacavir sulfate GlaxoSmithKline 020977 SE2 012   10/3/03 8/2/04 10.0 Provides for the use of Ziagen (abacavir sulfate, 600 mg) tablets once daily in combination with other antiretroviral agents for the treatment of HIV-1 infection.
topiramate Ortho McNeil Pharm 020505 SE1 022   12/23/02 8/11/04 19.6 Provides for the use of topiramate tablets for migraines prophylaxis.
topiramate Ortho McNeil Pharm 020844 SE1 019   12/23/02 8/11/04 19.6 Provides for the use of topiramate capsules for migraine prophylaxis.
mixed salt of single entity amphetamine Shire Labs 021303 SE5 005   12/18/02 8/11/04 19.8 Provides for the use of Adderall XR in the treatment of adult attention deficient hyperactivity disorder (ADHD).
sodium ferric gluconate complex in sucrose Watson Pharms 020955 SE5 006 Y 2/13/04 8/13/04 6.0 Provides for the use of Ferrlecit for the treatment of iron deficiency anemia in pediatric patients age 6 years and older, undergoing chronic hemodialysis and receiving supplemental erythropoietin therapy.
docetaxel Aventis Pharms 020449 SE1 029 Y 3/17/04 8/18/04 5.1 Provides for the use of Taxotere® (docetaxel) in combination with doxorubicin and cyclophosphamide for the adjuvant treatment of patients with operable node positive breast cancer.
ziprasidone hydrochloride Pfizer 020825 SE1 009   10/21/03 8/19/04 10.0 Provides for the use of Geodon® Capsules as monotherapy in the treatment of acute manic or mixed episodes in Bipolar I Disorder, with or without psychotic features.
pemetrexed disodium Lilly 021677 N 000   11/4/03 8/19/04 9.5 Provides for the use of Alimta® (pemetrexed for injection) as a single-agent for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after prior chemotherapy.
rofecoxib Merck 021042 SE5 026 Y 12/5/03 8/19/04 8.5 Provides for the use of VioxxTM tablets for relief of the signs and symptoms of pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis in patients 2 years and older and who weigh 10 kg (22 lbs) or more.
rofecoxib Merck 021052 SE5 019 Y 12/5/03 8/19/04 8.5 Provides for the use of VioxxTM suspension for relief of the signs and symptoms of pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis in patients 2 years and older and who weigh 10 kg (22 lbs) or more.
tegaserod maleate Novartis 021200 SE1 005   10/21/03 8/21/04 10.0 Provides for the use of Zelnorm® (tegaserod maleate) tablets for the treatment of patients less than 65 years of age with chronic idiopathic constipation.
somatropin (rDNA origin) Serono 019764 SE1 020   7/1/2002 8/26/04 25.9* Provides for the use of Saizen (somatropin (rDNA origin)) for the replacement of endogenous growth hormone in adults with growth hormone deficiency
duloxetine Lilly 021733 N 000 Y 3/3/04 9/3/04 6.0 Provides for the use of Cymbalta (duloxetine hydrochloride) Delayed release Capsules 20, 30 and 60 mg for the management of neuropathic pain associated with diabetic peripheral neuropathy.
multi-vitamin infusion without vitamin K Mayne Pharma 008809 SE1 054 Y 8/23/04 9/9/04 0.6 Provides for the prevention of vitamin deficiency and thromboembolic complications in people receiving home parenteral nutrition who also receive warfarin-type anticoagulant therapy.
aripiprazole Otsuka 021436 SE1 002   6/25/03 9/29/04 15.2 Provides for the use of Abilify® Tablets in the treatment of acute manic or mixed episodes associated with bipolar disorder.
caspofungin acetate Merck 021227 SE1 012   9/9/03 9/29/04 12.7 Provides for the use of Cancidas® (caspofungin acetate) for Injection for empirical therapy of presumed fungal infections in febrile, neutropenic patients (ETFN).
miconazole nitrate Personal Products 021308 SE2 009   12/3/2003 10/1/2004 10.0 Proposes to change the labeling instructions for Monistat 1 Combination Pack (miconazole nitrate) to allow for daytime administration of the drug product, in addition to the current bedtime administration, to treat vulvovaginal candidiasis.
somatropin (rDNA origin) Novo Nordisk 021148 SE1 007   12/15/2003 10/13/2004 10.0* Provides for the use of Norditropin® (somatropin (rDNA origin)) to treat adults with growth hormone deficiency
sumatriptan GlaxoSmithKline 020626 SE5 004   3/1/2000 10/13/2004 55.5 Proposes for the use of Imitrex® (sumatriptan) nasal spray for the acute treatment of migraine in adolescents.
enfuvirtide Roche 021481 SE7 002   12/15/2003 10/15/2004 10.0 Provides for the use of Fuzeon® (enfuvirtide) for injection, in combination with other antiretroviral agents, for the treatment of HIV-1 infection in treatment experienced patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy. This supplemental application provides information to fulfill the accelerated approval commitments as required under CFR 314.510.
methylphenidate hydrochloride Alza 021121 SE1 008 Y 9/5/2003 10/21/2004 13.5 Provides for the use of Concerta® (methylphenidate HCl) Extended-Release Tablets in adolescents with attention deficit hyperactivity disorder (ADHD) and to expand the labeling to include a 72 mg dose
letrozole Novartis 020726 SE1 011 Y 4/29/2004 10/29/2004 6.0 Provides for the use of Femara® for the extended adjuvant treatment of early breast cancer in postmenopausal women who have received five years of adjuvant tamoxifen therapy
oxaliplatin Sanofi-Synthelabo 021492 SE1 004   1/8/2004 11/4/2004 9.9 Provides for the use of Eloxatin (oxaliplatin) in combination with infusional 5-FU/LV, for the adjuvant treatment of stage III colon cancer patients who have undergone complete resection of the primary tumor
mesalamine Axcan Scandipharm 021252 SE2 005   1/6/2004 11/5/2004 10 Provides for the addition of a new strength (1000 mg suppository)
zolmitriptan AstraZeneca 020768 SE5 012 Y 9/30/2003 11/16/2004 13.6 Proposes the use of Zomig (zolmitriptan) tablets for the acute treatment of migraine in adolescents
levofloxacin Ortho McNeil 021721 SE1 003 Y 11/12/2004 11/24/2004 0.4 Provides for the use of Levaquin® oral solution for the treatment of inhalational anthrax (post-exposure)
levofloxacin Ortho McNeil 020634 SE1 035 Y 5/26/2004 11/24/2004 6.0 Provides for the use of Levaquin® tablets for the treatment of inhalational anthrax (post-exposure)
levofloxacin Ortho McNeil 020635 SE1 035 Y 5/26/2004 11/24/2004 6.0 Provides for the use of Levaquin® injection for the treatment of inhalational anthrax (post-exposure)
treprostinil sodium United Therapeutics 021272 SE3 002   1/30/2004 11/24/2004 9.8 Provides for adding the infusion of Remodulin (treprostinil sodium) 1, 2.5, 5 & 10 mg/mL Injection via an indwelling central venous catheter to the labeling
esomeprazole magnesium AstraZeneca 021153 SE1 019   1/28/2004 11/24/2004 9.9 Provides for the use of Nexium® (esomeprazole magnesium) Delayed-
Release Capsules for the risk reduction of NSAID-associated gastric ulcers
pantoprazole Wyeth 020988 SE1 027   2/9/2004 12/6/2004 9.9 Provide for the use of Protonix I.V. for the short-term treatment of patients with gastroesophageal reflux disease and a history of erosive esophagitis
carbamazepine Shire 021710 N 000   2/13/2004 12/10/2004 9.9 Provides for the use of Equetro (carbamazepine) extended-release capsules as monotherapy in the acute treatment of manic or mixed symptoms associated with Bipolar I Disorder
anagrelide hydrochloride Shire 020333 SE5 008 Y 3/12/2004 12/10/2004 9.0 Provides for labeling changes based on results of the SPD422-202 clinical study report (CSR) for a pediatric study of Agrylin® (anagrelide hydrochloride) capsules
levothyroxine sodium Jerome Stevens 021210 SE4 003   10/28/2004 12/13/2004 18.7 We have determined your Unithroid (levothyroxine sodium tablets, USP) 25, 50, 75, 88, 100, 112, 125, 150, 175, 200, and 300 mcg tablets to be bioequivalent and therapeutically equivalent to the listed drug
Synthroid (levothyroxine sodium tablets, USP) 25, 50, 75, 88, 100, 112, 125, 150, 175, 200, and 300 mcg tablets.
mometasone furoate monohydrate Schering Plough 020762 SE1 023   2/26/2004 12/15/2004 9.6 Provides clinical support for the use of Nasonex (mometasone furoate monohydrate) Aqueous Nasal Spray, 50 mcg, for the treatment of nasal polyps in patients 18 years of age and older
icodextrin Baxter Healthcare 021321 SE1 010 Y 7/1/2004 12/17/2004 5.6 Provides for the use of Extraneal (icodextrin) Peritoneal Dialysis Solution to improve long dwell ultrafiltration as compared to 4.25% dextrose in patients with high average/high
transport characteristics
amoxicillin; clavulanate potassium GlaxoSmithKline 050755 SE5 012   2/23/2004 12/17/2004 9.8 Proposes a pediatric use statement for acute bacterial sinusitis (ABS) in the prescribing information of Augmentin ES-600® (amoxicillin/clavulanate potassium)
Powder for Oral Suspension, based on the extrapolation of the adult data from the Augmentin XR® ABS clinical program
voriconazole Pfizer 021266 SE1 009   3/16/2004 12/21/2004 9.2 Provides for the use of Vfend tablets for candidemia in nonneutropenic patients and the following Candida infections: disseminated infections in skin and infections in abdomen, kidney, bladder wall, and wounds
voriconazole Pfizer 021267 SE1 009   3/16/2004 12/21/2004 9.2 Provides for the use of Vfend I.V. for candidemia in nonneutropenic patients and the following Candida infections: disseminated infections in skin and
infections in abdomen, kidney, bladder wall, and wounds
voriconazole Pfizer 021630 SE1 003   3/16/2004 12/21/2004 9.2 Provides for the use of Vfend oral suspension for candidemia in nonneutropenic patients and the following Candida infections: disseminated infections in skin and infections in abdomen, kidney, bladder wall, and wounds
pregabalin Pfizer 021723 N 000   10/31/2003 12/30/2004 14.0 Provides for the use of Lyrica (pregabalin) capsules for the management of postherpetic neuralgia

 

      
* N 19764 SE1-020, somatropin, received tentative approval on August 26, 2004

 

 
NDA Efficacy Supplements Approved (SE8)
Established Name Applicant NDA Number Supp Type Supp Number Priority Review Receipt Date Approval Date Total Approval Time (Months)
lamotrigine GlaxoSmithKline 020241 SE8 016   12/10/01 1/14/04 25.1
lamotrigine GlaxoSmithKline 020764 SE8 009   12/10/01 1/14/04 25.1
sevelamer hydrochloride Genzyme 020926 SE8 006   5/31/02 2/6/04 20.3
sevelamer hydrochloride Genzyme 021179 SE8 002   5/6/02 2/6/04 21.1
omeprazole AstraZeneca 019810 SE8 058   10/7/98 2/23/04 64.6
zoledronic acid Novartis 021386 SE8 001   10/17/02 2/27/04 16.4
finasteride Merck 020180 SE8 026   6/12/03 4/12/04 10.0
tolterodine Pharmacia And Upjohn 021228 SE8 006 Y 10/14/03 4/14/04 6.0
alendronate sodium Merck 020560 SE8 041   6/19/03 4/16/04 9.9
gemtuzumab ozogamicin Wyeth Pharms Inc 021174 SE8 012   6/16/03 4/16/04 10.0
valdecoxib Gd Searle Llc 021341 SE8 003   6/24/03 4/23/04 10.0
lansoprazole Tap Pharm 021428 SE8 004 Y 12/22/03 6/17/04 5.9
lansoprazole Tap Pharm 021281 SE8 014 Y 12/22/03 6/17/04 5.9
irinotecan hydrochloride Pharmacia And Upjohn 020571 SE8 021 Y 12/24/03 6/24/04 6.0
oxybutynin chloride Alza 020897 SE8 013   9/3/03 6/30/04 9.9
budesonide AstraZeneca 020746 SE8 016   10/1/03 7/30/04 10.0
efavirenz Bristol Myers Squibb 020972 SE8 022   10/14/03 8/13/04 10.0
efavirenz Bristol Myers Squibb 021360 SE8 006   10/14/03 8/13/04 10.0
sertraline hydrochloride Pfizer 019839 SE8 047   2/26/03 8/19/04 17.8
sertraline HCl Pfizer 020990 SE8 013   2/26/03 8/19/04 17.8
adefovir dipivoxil Gilead 021449 SE8 003   10/23/03 8/19/04 9.9
dutasteride

GlaxoSmithKline

021319 SE8 008   11/14/03 9/14/04 10.0
lopinavir; ritonavir Abbott 021226 SE8 014   12/22/2003 10/19/2004 9.9
lopinavir; ritonavir Abbott 021251 SE8 010   12/30/2003 10/19/2004 9.7
orlistat HLR 020766 SE8 019   12/23/2003 10/22/2004 10.0
doxorubicin hydrochloride

Alza

050718 SE8 019   12/29/2003 10/27/2004 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
interferon gamma-1b Intermune BL103836 5033 Y 9/17/03 3/18/04 6.05 Includes safety and efficacy data in pediatric patients with chronic granulomatous disease (CGD)
interferon beta-1a Serono BL103780 5027   5/29/03 3/26/04 9.92 Includes a 22 mcg dosage strength for injection three times per week
etanercept Immunex BL103795 5149   7/1/03 4/30/04 9.95 New indication for the treatment of adult patients (18 years or older) with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy
epoetin alfa Amgen BL103234 5033   10/16/02 5/21/04 19.16 Updates the Clinical Experience Cancer Patients on Chemotherapy subsection of the package insert; revisions to the Warnings section and revisions to the Precautions section of the package insert to include information regarding the observed effects of epoetin alfa and other products in this class on response rate, time-to-progression and survival in patients with non-myeloid tumors
epoetin alfa Amgen BL103234 5053   9/4/03 6/30/04 9.85 Updates the Clinical Pharmacology, Indications and Usage, Precautions, Adverse Reactions, and Dosage Administration sections of the package insert to incorporate an alternative weekly dosing regimen for the treatment of anemia due to chemotherapy in patients with non-myeloid malignancies
botulinum toxin type A Allergan BL103000 5050   7/10/03 7/19/04 12.31 New indication for primary axillary hyperhidrosis
adalimumab Abbott BL125057 16   10/2/03 7/30/04 9.90 Expands the indication to include improving physical function in adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more DMARDS
etanercept Immunex BL103795 5162   11/25/03 9/24/04 9.97 Revises the Clinical Studies, Adverse Reactions, and Indications and Usage sections of the package insert (PI) and the Patient Package Insert (PPI)
etanercept Immunex BL103795 5184   5/28/04 9/27/04 3.97 New formulation and presentation of drug product (DP): 50 mg/mL liquid supplied in a single dose pre-filled syringe (PFS)
infliximab Centocor BL103772 5073   12/1/03 9/29/04 9.90 Expands the indication to include patients with earlier stage rheumatoid arthritis with moderate to severe disease activity not previously treated with methotrexate
ibritumomab tiuxetan IDEC BL125019 58   9/24/2003 10/22/2004 12.94 Revises the Clinical Pharmacology, Clinical Studies, Warnings, Precautions, Dosage and Administration, and Image Acquisitions and Interpretation sections of the package insert
alefacept Biogen BL 125036 25   2/11/2004 12/10/2004 9.97 Revises the Clinical Studies section of the package insert to describe the median duration of response after treatment with the intramuscular formulation
infliximab Centocor BL 103722 5077   2/17/2004 12/17/2004 10.00 Treatment of active ankylosing spondylitis
tositumomab and iodine I 131 tositumomab Corixa BL 125011 24 Y 7/3/2004 12/22/2004 5.61 Expands the indication to include patients with relapsed or refractory, low grade, follicular or transformed CD20 positive non-Hodgkin's lymphoma who have not received rituximab

 

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 12/31/04