Drugs

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 besylatePfizer019787SE5030 9/17/011/8/0427.7Provides 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
oxaliplatinSanofi021492SE1002Y7/11/031/9/046.0Provides 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 fumarateAstraZeneca020639SE1016 12/30/021/12/0412.4Provides for the use of Seroquel (quetiapine fumarate) tablets as monotherapy in the treatment of acute manic episodes associated with Bipolar I disorder
quetiapine fumarateAstraZeneca020639SE1017 12/30/021/12/0412.4Provides 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
olanzapineLilly020592SE1019 11/21/021/14/0413.8Provides for the use of olanzapine in the long-term treatment of bipolar I disorder
azithromycinPfizer050784SE1004 3/17/031/15/0410.0Provides for treatment of acute bacterial sinusitis using a 3-day regimen of Zithromax (azithromycin) Tablets 
modafinilCephalon020717SE1008 12/20/021/23/0413.1Provides 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 hydrochlorideGlaxoSmithKline020936SE2013 3/27/031/27/0410.1Provides for the use of Paxil CR in the treatment of premenstrual dysphoric disorder (PMDD) using an intermittent dosing regimen
synthetic conjugated estrogens ADuramed020992SE2021 8/2/022/5/0418.1Provides 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 hydrochlorideNovartis019851SE5028Y4/25/033/2/0410.3Proposes 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
imiquimod3M020723SE1015 5/2/033/2/0410.0Provides 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.
leflunomideAventis Pharms020905SE5012Y9/5/033/5/046.0Provides for additional language to the CLINICAL PHARMACOLOGY, CLINICAL STUDIES and ADVERSE REACTIONS sections of the label
remifentanil hydrochlorideAbbott020630SE5005 1/6/003/8/0450.1Provides 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 potassiumMerck020386SE5029 12/21/013/11/0426.7Provides 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 hydrochlorideBristol Myers Squibb021178SE5007Y7/21/033/15/047.8Provides 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 mesylateAgouron020778SE5022Y6/20/033/19/049.0Provides 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 mesylateAgouron020779SE5042Y6/20/033/19/049.0Provides 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 mesylateAgouron021503SE5001Y6/20/033/19/049.0Provides 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
ciprofloxacinBayer Pharms019537SE5049Y9/25/033/25/046.0Provides 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 Pharms019847SE5027Y9/29/033/25/045.9Provides 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 Pharms019857SE5031Y9/29/033/25/045.9Provides 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 Pharms020780SE5013Y9/29/033/25/045.9Provides 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
rofecoxibMerck021647N000 5/27/033/26/0410.0Provides for the use of Vioxx (rofecoxib) for the acute treatment of migraine in adults
paricalcitolAbbott020819SE5014Y9/30/033/31/046.0Provides for the use of Zemplar (paricalcitol) Injection in pediatric patients with Stage 5 chronic kidney disease (end-stage renal disease)
fenoldopam mesylateAbbott019922SE5005Y10/1/034/1/046.0Provides 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 hydrochlorideBiovail021392SE1002 6/9/034/2/049.8Provides for the use of Cardizem LA (diltiazem hydrochloride) 120, 180, 240, 300, 360 and 420 mg for the management of chronic stable angina
abacavir sulfateGlaxoSmithKline020978SE7013 6/16/034/15/0410.0Provides 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 sulfateGlaxoSmithKline020977SE7011 6/16/034/15/0410.0Provides 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 hydrochlorideMerck020408SE5033Y10/17/034/15/046.0Provides 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 GlaxoSmithKline021077SE5017 6/27/034/21/049.8Provides for the use of Advair Diskus 100/50 mcg in children 4 to 11 years of age with asthma.
doxercalciferolBone Care020862SE1006 12/27/014/23/0427.9Proposes 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 Labs021620N000 6/30/034/29/0410.0Provides for the use of Mucinex™DM (guaifenesin and dextromethorphan HBr) Extended-release Tablets as an expectorant and antitussive.
venlafaxine hydrochlorideWyeth Pharms020151SE5024Y9/26/025/5/0419.3Provides for additional safety data in the pediatric population for Effexor (venlafaxine hydrochloride) Immediate Release Tablets.
venlafaxine hydrochlorideWyeth Pharms020699SE5030Y9/26/025/5/0419.3Provides for additional safety data in the pediatric population for Effexor XR (venlafaxine hydrochloride) Extended Release Capsules.
tinidazolePresutti Labs021681N000 7/17/035/17/0410.0Provide for the use of Tindamax™ (tinidazole tablets) for the treatment of giardiasis.
tinidazolePresutti Labs021682N000 7/17/035/17/0410.0Provide for the use of Tindamax™ (tinidazole tablets) for the treatment of amebiasis and amebic liver abscess.
moxifloxacin hydrochlorideBayer Pharms021277SE1017Y2/18/045/18/043.0Provides for the use of Avelox® I.V. for the treatment of Community Acquired Pneumonia caused by multi-drug resistant Streptococcus pneumoniae. 
moxifloxacin hydrochlorideBayer Pharms021085SE1022Y2/18/045/18/043.0Provides for the use of Avelox® tablets for the treatment of Community Acquired Pneumonia caused by multi-drug resistant Streptococcus pneumoniae. 
docetaxelAventis Pharms020449SE1028Y1/27/045/19/043.7Provides for the use of Taxotere® (docetaxel) in combination with prednisone as a treatment for patients with androgen independent (hormone refractory) metastatic prostate cancer.
gemcitabine hydrochlorideLilly020509SE1029Y12/18/035/19/045.0Provides 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.
epinephrineHollister Stier Labs020800SE5001 7/28/035/28/0410.0Indicated for the emergency treatment of severe allergic reactions, including anaphylaxis in patients who weigh 15-30 kg (approximately 33-66 Lbs).
fondaparinux sodiumFonda Bv021345SE1005 7/31/035/28/049.9Provides for the use of Arixtra (fondaparinux sodium) Injection for the treatment of acute pulmonary embolism when administered in conjunction with warfarin sodium.
fondaparinux sodiumFonda Bv021345SE1004 7/31/035/28/049.9Provides 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 insulinLilly020563SE3024 12/21/996/2/0453.4Provides 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 transdermalBerlex Labs021674N000 8/8/036/8/0410.0Provides for the use of Menostar (estradiol transdermal system) for prevention of postmenopausal osteoporosis.
lansoprazoleTap Pharm020406SE5057Y12/23/036/17/045.8Provides 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 sodiumStevens J021210SE4002 3/27/036/23/0414.9Establishes 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 sodiumAlara Pharm021342SE4004 6/12/036/23/0412.4Establishes 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 sodiumAlara Pharm021342SE4003 4/2/036/23/0414.7Establishes 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.
linezolidPharmacia And Upjohn021131SE5007Y12/23/036/23/046.0Provides 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]).
linezolidPharmacia And Upjohn021132SE5006Y12/23/036/23/046.0Provides 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]).
linezolidPharmacia And Upjohn021130SE5006Y12/23/036/23/046.0Provides 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]).
gatifloxacinBristol Myers Squibb021061SE1022Y12/30/036/30/046.0Provides for the use of Tequin® (gatifloxacin) Tablets for the treatment of Community Acquired Pneumonia caused by multi-drug resistant Streptococcus pneumoniae.
gatifloxacinBristol Myers Squibb021062SE1023Y12/30/036/30/046.0Provides 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 sulfateBristol Myers Squibb021567SE2002 10/31/037/6/048.2Provides for a new dosing regimen of Reyataz® (atazanavir) 300mg/ritonavir 100mg once daily for treatment in HIV-infected antiretroviral-experienced patients.
levofloxacinOrtho McNeil Pharm020634SE1030Y3/3/047/14/044.4Provides for the use of Levaquin® (levofloxacin) Tablets for the treatment of Community Acquired Pneumonia caused by Multi-Drug Resistant Streptococcus pneumoniae.
levofloxacinOrtho McNeil Pharm020635SE1030Y3/3/047/14/044.4Provides 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.
imiquimod3M020723SE1016 6/10/037/14/0413.2Provides 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.
meloxicamBoehringer Ingelheim020938SE1004 2/28/017/16/0440.6Provides 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.
nitazoxanideRomark021498SE1002 7/19/047/21/040.1Provides 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.
ursodiolAxcan Scandipharm020675SE2009 9/22/037/21/0410.0Provides 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 T1-201Mallinckrodt018150SE1019 9/30/037/23/049.8Provides 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 sulfateSchering019670SE1019 3/10/047/30/044.7Provides 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 sulfateSchering020470SE1022 3/10/047/30/044.7Provides 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 calciumPfizer020702SE1039 10/1/037/30/0410.0Provides 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 sulfateGlaxoSmithKline020978SE2014 10/3/038/2/0410.0Provides 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 sulfateGlaxoSmithKline020977SE2012 10/3/038/2/0410.0Provides 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.
topiramateOrtho McNeil Pharm020505SE1022 12/23/028/11/0419.6Provides for the use of topiramate tablets for migraines prophylaxis.
topiramateOrtho McNeil Pharm020844SE1019 12/23/028/11/0419.6Provides for the use of topiramate capsules for migraine prophylaxis.
mixed salt of single entity amphetamineShire Labs021303SE5005 12/18/028/11/0419.8Provides for the use of Adderall XR in the treatment of adult attention deficient hyperactivity disorder (ADHD).
sodium ferric gluconate complex in sucroseWatson Pharms020955SE5006Y2/13/048/13/046.0Provides 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.
docetaxelAventis Pharms020449SE1029Y3/17/048/18/045.1Provides 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 hydrochloridePfizer020825SE1009 10/21/038/19/0410.0Provides 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 disodiumLilly021677N000 11/4/038/19/049.5Provides 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.
rofecoxibMerck021042SE5026Y12/5/038/19/048.5Provides 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.
rofecoxibMerck021052SE5019Y12/5/038/19/048.5Provides 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 maleateNovartis021200SE1005 10/21/038/21/0410.0Provides 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)Serono019764SE1020 7/1/20028/26/0425.9*Provides for the use of Saizen (somatropin (rDNA origin)) for the replacement of endogenous growth hormone in adults with growth hormone deficiency
duloxetineLilly021733N000Y3/3/049/3/046.0Provides 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 KMayne Pharma008809SE1054Y8/23/049/9/040.6Provides for the prevention of vitamin deficiency and thromboembolic complications in people receiving home parenteral nutrition who also receive warfarin-type anticoagulant therapy.
aripiprazoleOtsuka021436SE1002 6/25/039/29/0415.2Provides for the use of Abilify® Tablets in the treatment of acute manic or mixed episodes associated with bipolar disorder.
caspofungin acetateMerck021227SE1012 9/9/039/29/0412.7Provides for the use of Cancidas® (caspofungin acetate) for Injection for empirical therapy of presumed fungal infections in febrile, neutropenic patients (ETFN).
miconazole nitratePersonal Products021308SE2009 12/3/200310/1/200410.0Proposes 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 Nordisk021148SE1007 12/15/200310/13/200410.0*Provides for the use of Norditropin® (somatropin (rDNA origin)) to treat adults with growth hormone deficiency
sumatriptanGlaxoSmithKline020626SE5004 3/1/200010/13/200455.5Proposes for the use of Imitrex® (sumatriptan) nasal spray for the acute treatment of migraine in adolescents.
enfuvirtideRoche021481SE7002 12/15/200310/15/200410.0Provides 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 hydrochlorideAlza021121SE1008Y9/5/200310/21/200413.5Provides 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
letrozoleNovartis020726SE1011Y4/29/200410/29/20046.0Provides 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
oxaliplatinSanofi-Synthelabo021492SE1004 1/8/200411/4/20049.9Provides 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
mesalamineAxcan Scandipharm021252SE2005 1/6/200411/5/200410Provides for the addition of a new strength (1000 mg suppository)
zolmitriptanAstraZeneca020768SE5012Y9/30/200311/16/200413.6Proposes the use of Zomig (zolmitriptan) tablets for the acute treatment of migraine in adolescents
levofloxacinOrtho McNeil021721SE1003Y11/12/200411/24/20040.4Provides for the use of Levaquin® oral solution for the treatment of inhalational anthrax (post-exposure)
levofloxacinOrtho McNeil020634SE1035Y5/26/200411/24/20046.0Provides for the use of Levaquin® tablets for the treatment of inhalational anthrax (post-exposure)
levofloxacinOrtho McNeil020635SE1035Y5/26/200411/24/20046.0Provides for the use of Levaquin® injection for the treatment of inhalational anthrax (post-exposure)
treprostinil sodiumUnited Therapeutics021272SE3002 1/30/200411/24/20049.8Provides 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 magnesiumAstraZeneca021153SE1019 1/28/200411/24/20049.9Provides for the use of Nexium® (esomeprazole magnesium) Delayed-
Release Capsules for the risk reduction of NSAID-associated gastric ulcers
pantoprazoleWyeth020988SE1027 2/9/200412/6/20049.9Provide for the use of Protonix I.V. for the short-term treatment of patients with gastroesophageal reflux disease and a history of erosive esophagitis
carbamazepineShire021710N000 2/13/200412/10/20049.9Provides 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 hydrochlorideShire020333SE5008Y3/12/200412/10/20049.0Provides for labeling changes based on results of the SPD422-202 clinical study report (CSR) for a pediatric study of Agrylin® (anagrelide hydrochloride) capsules
levothyroxine sodiumJerome Stevens021210SE4003 10/28/200412/13/200418.7We 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 monohydrateSchering Plough020762SE1023 2/26/200412/15/20049.6Provides 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
icodextrinBaxter Healthcare021321SE1010Y7/1/200412/17/20045.6Provides 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 potassiumGlaxoSmithKline050755SE5012 2/23/200412/17/20049.8Proposes 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
voriconazolePfizer021266SE1009 3/16/200412/21/20049.2Provides 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
voriconazolePfizer021267SE1009 3/16/200412/21/20049.2Provides 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
voriconazolePfizer021630SE1003 3/16/200412/21/20049.2Provides 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
pregabalinPfizer021723N000 10/31/200312/30/200414.0Provides 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 NameApplicantNDA NumberSupp TypeSupp NumberPriority ReviewReceipt DateApproval DateTotal Approval Time (Months)
lamotrigineGlaxoSmithKline020241SE8016 12/10/011/14/0425.1
lamotrigineGlaxoSmithKline020764SE8009 12/10/011/14/0425.1
sevelamer hydrochlorideGenzyme020926SE8006 5/31/022/6/0420.3
sevelamer hydrochlorideGenzyme021179SE8002 5/6/022/6/0421.1
omeprazoleAstraZeneca019810SE8058 10/7/982/23/0464.6
zoledronic acidNovartis021386SE8001 10/17/022/27/0416.4
finasterideMerck020180SE8026 6/12/034/12/0410.0
tolterodinePharmacia And Upjohn021228SE8006Y10/14/034/14/046.0
alendronate sodiumMerck020560SE8041 6/19/034/16/049.9
gemtuzumab ozogamicinWyeth Pharms Inc021174SE8012 6/16/034/16/0410.0
valdecoxibGd Searle Llc021341SE8003 6/24/034/23/0410.0
lansoprazoleTap Pharm021428SE8004Y12/22/036/17/045.9
lansoprazoleTap Pharm021281SE8014Y12/22/036/17/045.9
irinotecan hydrochloridePharmacia And Upjohn020571SE8021Y12/24/036/24/046.0
oxybutynin chlorideAlza020897SE8013 9/3/036/30/049.9
budesonideAstraZeneca020746SE8016 10/1/037/30/0410.0
efavirenzBristol Myers Squibb020972SE8022 10/14/038/13/0410.0
efavirenzBristol Myers Squibb021360SE8006 10/14/038/13/0410.0
sertraline hydrochloridePfizer019839SE8047 2/26/038/19/0417.8
sertraline HClPfizer020990SE8013 2/26/038/19/0417.8
adefovir dipivoxilGilead021449SE8003 10/23/038/19/049.9
dutasteride

GlaxoSmithKline

021319SE8008 11/14/039/14/0410.0
lopinavir; ritonavirAbbott021226SE8014 12/22/200310/19/20049.9
lopinavir; ritonavirAbbott021251SE8010 12/30/200310/19/20049.7
orlistatHLR020766SE8019 12/23/200310/22/200410.0
doxorubicin hydrochloride

Alza

050718SE8019 12/29/200310/27/200410.0
  BLA Efficacy Supplements Approved
Proper NameApplicantBLA NumberSupp NumberPriority ReviewReceipt DateApproval DateTotal Approval Time (Months)Indication/Description
interferon gamma-1bIntermuneBL1038365033Y9/17/033/18/046.05Includes safety and efficacy data in pediatric patients with chronic granulomatous disease (CGD)
interferon beta-1aSeronoBL1037805027 5/29/033/26/049.92Includes a 22 mcg dosage strength for injection three times per week
etanerceptImmunexBL1037955149 7/1/034/30/049.95New 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 alfaAmgenBL1032345033 10/16/025/21/0419.16Updates 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 alfaAmgenBL1032345053 9/4/036/30/049.85Updates 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 AAllerganBL1030005050 7/10/037/19/0412.31New indication for primary axillary hyperhidrosis
adalimumabAbbottBL12505716 10/2/037/30/049.90Expands 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
etanerceptImmunexBL1037955162 11/25/039/24/049.97Revises the Clinical Studies, Adverse Reactions, and Indications and Usage sections of the package insert (PI) and the Patient Package Insert (PPI)
etanerceptImmunexBL1037955184 5/28/049/27/043.97New formulation and presentation of drug product (DP): 50 mg/mL liquid supplied in a single dose pre-filled syringe (PFS)
infliximabCentocorBL1037725073 12/1/039/29/049.90Expands the indication to include patients with earlier stage rheumatoid arthritis with moderate to severe disease activity not previously treated with methotrexate
ibritumomab tiuxetanIDECBL12501958 9/24/200310/22/200412.94Revises the Clinical Pharmacology, Clinical Studies, Warnings, Precautions, Dosage and Administration, and Image Acquisitions and Interpretation sections of the package insert
alefaceptBiogenBL 12503625 2/11/200412/10/20049.97Revises the Clinical Studies section of the package insert to describe the median duration of response after treatment with the intramuscular formulation
infliximabCentocorBL 1037225077 2/17/200412/17/200410.00Treatment of active ankylosing spondylitis
tositumomab and iodine I 131 tositumomabCorixaBL 12501124Y7/3/200412/22/20045.61Expands 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 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 12/31/04

 

 

Page Last Updated: 11/23/2015
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English