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 |