Generic Name |
Applicant |
NDA Number |
Supp Type |
Supp Number |
Priority Review |
Receipt Date |
Approval Date |
Total Approval Time (Months) |
Indication/Description |
eplerenone |
GD Searle |
021437 |
SE1 |
002 |
Y |
4/7/2003 |
10/7/2003 |
6 |
Provides for the use of
Inspra (eplerenone) Tablets to improve survival of stable
patients with left ventricular systolic dysfunction
(ejection fraction <
40%) and clinical evidence of congestive heart failure after
an acute myocardial infarction. |
penciclovir |
Novartis |
020629 |
SE5 |
008 |
|
12/11/2002 |
10/10/2003 |
10 |
Provides for the use of
Denavir (penciclovir cream) 1% for the treatment of
recurrent herpes labialis (RHL) in children 12 and older. |
paroxetine hydrochloride |
GlaxoSmithKline |
020936 |
SE1 |
012 |
|
12/20/2002 |
10/16/2003 |
9.9 |
Provides for the use of Paxil
CR (paroxetine hydrochloride) Controlled-Release Tablets for
the treatment of social anxiety disorder. |
nateglinide |
Novartis |
021204 |
SE1 |
006 |
|
12/20/2002 |
10/20/2003 |
10 |
Provides for an expanded
indication for the use of Starlix (nateglinide) Tablets, in
combination with antidiabetic drugs in the thiazolidinedione
class. |
levofloxacin |
Ortho McNeil |
020635 |
SE2 |
027 |
|
12/23/2002 |
10/23/2003 |
10 |
Provides for the use of
Levaquin Injection for Community Acquired Pneumonia (CAP)
with a new dosing regimen of 750 mg once daily for 5 days. |
levofloxacin |
Ortho McNeil |
020634 |
SE2 |
028 |
|
12/23/2002 |
10/23/2003 |
10 |
Provides for the use of
Levaquin Tablets for Community Acquired Pneumonia (CAP) with
a new dosing regimen of 750 mg once daily for 5 days. |
voriconazole |
Pfizer |
021466 |
N |
000 |
|
11/17/2000 |
11/14/2003 |
35.9 |
Provides for the use of VFEND
(voriconazole for injection) I.V. for esophageal
candidiasis. |
voriconazole |
Pfizer |
021464 |
N |
000 |
|
11/17/2000 |
11/14/2003 |
35.9 |
Provides for the use of VFEND
(voriconazole) Tablets for esophageal candidiasis. |
salmeterol/fluticasone
propionate |
GlaxoSmithKline |
021077 |
SE1 |
003 |
|
5/7/2001 |
11/17/2003 |
30.4 |
Provides for the use of
Advair Diskus 250/50 (fluticasone propionate and salmeterol
xinafoate inhalation powder) for Chronic Obstructive
Pulmonary Disease associated with Chronic Bronchitis. |
loratadine |
Schering |
020641 |
SE6 |
011 |
|
1/28/2002 |
11/19/2003 |
21.7 |
Provides for over-the-counter
use of Claritin (loratadine) Syrup for the relief of itching
due to hives (urticaria) to be marketed under the tradename,
Claritin Hives Relief. |
loratadine |
Schering |
020704 |
SE6 |
009 |
|
1/28/2002 |
11/19/2003 |
21.7 |
Provides for over-the-counter
use of Claritin (loratadine) Reditabs for the relief of
itching due to hives (urticaria) to be marketed under the
tradename, Claritin Hives Relief. |
loratadine |
Schering |
019658 |
SE6 |
020 |
|
1/28/2002 |
11/19/2003 |
21.7 |
Provides for over-the-counter
use of Claritin (loratadine) Tablets for the relief of
itching due to hives (urticaria) to be marketed under the
tradename, Claritin Hives Relief. |
somatropin [rDNA origin] |
Serono |
021597 |
N |
000 |
|
11/1/2002 |
12/1/2003 |
13 |
Provides for the use of
Zorbtive [somatotropin (rDNA origin) for injection] for the
treatment of Short Bowel Syndrome in patients receiving
specialized nutritional support. |
atovaquone; proguanil
hydrochloride |
GlaxoSmithKline |
021078 |
SE5 |
006 |
Y |
6/2/2003 |
12/2/2003 |
6 |
Provides for the use of
Malarone (atovaquone and proguanil hydrochloride) Pediatric
Tablets, 62.5 mg/25 mg for the treatment of Plasmodium
falciparum malaria in
pediatric patients weighing 5 kg to 11 kg. |
risperidone |
Janssen |
020588 |
SE1 |
018 |
|
12/16/2002 |
12/4/2003 |
11.6 |
Provides for Adjunctive
Therapy - for short term treatment of acute manic or mixed
episodes associated with Bipolar I Disorder (oral
suspension) |
risperidone |
Janssen |
020588 |
SE1 |
017 |
|
12/16/2002 |
12/4/2003 |
11.6 |
Provides for Monotherapy -
for short term treatment of acute manic or mixed episodes
associated with Bipolar I Disorder (oral suspension) |
risperidone |
Janssen |
020272 |
SE1 |
027 |
|
12/16/2002 |
12/4/2003 |
11.6 |
Provides for Adjunctive
Therapy - for short term treatment of acute manic or mixed
episodes associated with Bipolar I Disorder (tablets) |
risperidone |
Janssen |
020272 |
SE1 |
026 |
|
12/16/2002 |
12/4/2003 |
11.6 |
Provides for Monotherapy -
for short term treatment of acute manic or mixed episodes
associated with Bipolar I Disorder (tablets) |
risperidone |
Janssen |
021444 |
SE1 |
002 |
|
8/15/2003 |
12/4/2003 |
3.6 |
Provides for Monotherapy -
for short term treatment of acute manic or mixed episodes
associated with Bipolar I Disorder (orally disintegrating
tablets) |
risperidone |
Janssen |
021444 |
SE1 |
003 |
|
8/15/2003 |
12/4/2003 |
3.6 |
Provides for Adjunctive
Therapy - for short term treatment of acute manic or mixed
episodes associated with Bipolar I Disorder (orallly
disintegrating tablets) |
imatinib mesylate |
Novartis |
021588 |
SE7 |
002 |
|
8/28/2003 |
12/8/2003 |
3.4 |
Provides for a revised
package insert with updated data and fulfills the prior
accelerated postmarketing commitment #2 under NDA
21-588/N-000 "To provide interval follow-up information on
studies 102, 109 and 110" for the use of Gleevec (imatinib
mesylate) Tablets for the treatment of patients with
Philadelphia chromosome positive chronic myeloid leukemia
(CML) in blast crisis, accelerated phase, or in chronic
phase after failure of interferon-alfa therapy. |
dalteparin sodium |
Pharmacia & Upjohn |
020287 |
SE1 |
032 |
|
2/10/2003 |
12/10/2003 |
10 |
Provides for the use of
Fragmin (dalteparin sodium) injection for the prophylaxis of
deep vein thrombosis (DVT), which may lead to pulmonary
embolism (PE) in patients who are at risk for thromboembolic
complications due to severely restricted mobility during
acute illness. |
orlistat |
HLR |
020766 |
SE5 |
018 |
Y |
6/24/2003 |
12/12/2003 |
5.6 |
Provides for revised labeling
to provide for use of Xenical Capsules in the management of
obesity in adolescent patients aged 12 to 16 years. |
topiramate |
Ortho McNeil |
020505 |
SE2 |
017 |
|
7/1/2002 |
12/16/2003 |
17.5 |
Provides for a change in the
recommended daily dose of topiramate and an update to the
relevant clinical/safety sections of labeling based on
results of the TOPMAT-EPAJ-119 study. |
topiramate |
Ortho Mcneil |
020844 |
SE2 |
014 |
|
7/1/2002 |
12/16/2003 |
17.5 |
Provides for a change in the
recommended daily dose of topiramate and an update to the
relevant clinical/safety sections of labeling based on
results of the TOPMAT-EPAJ-119 study. |
escitalopram oxalate |
Forest |
021323 |
SE1 |
003 |
|
11/27/2002 |
12/18/2003 |
12.7 |
Provides for the treatment of
generalized anxiety disorder (tablets). |
escitalopram oxalate |
Forest |
021365 |
SE1 |
004 |
|
5/22/2003 |
12/18/2003 |
6.9 |
Provides for the treatment of
generalized anxiety disorder (oral solution). |
saquinavir |
HLR |
020628 |
SE2 |
020 |
|
2/24/2003 |
12/24/2003 |
10 |
Provides for the use of
INVIRASE (1000 mg twice daily) coadministered with ritonavir
(100 mg twice daily) and in combination with other
antiretroviral drugs, for the treatment of HIV infection.
The new dosing regimen replaces the previously approved
regimen for INVIRASE. |
saquinavir |
HLR |
020828 |
SE2 |
015 |
|
2/24/2003 |
12/24/2003 |
10 |
Provides for the use of an
additional dosing regimen of FORTOVASE (saquinavir) Soft
Gelatin Capsules (1000 mg twice daily coadministered with
ritonavir 100 mg twice daily) and in combination with other
antiretroviral drugs, for the treatment of HIV infection. |
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, 500 mg |
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 |
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