Drugs
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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
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