GENERIC NAME |
APPLICANT |
NDA NUMBER |
SUPP TYPE |
SUPP NUMBER |
RECEIPT DATE |
APPROVAL DATE |
PRIORITY REVIEW |
TOTAL APPROVAL TIME (MONTHS) |
INDICATION/DESCRIPTION |
FLUOXETINE
HYDROCHLORIDE |
LILLY RES LABS |
18-936 |
SE5 |
064 |
15-Sep-00 |
3-Jan-03 |
|
27.6 |
Provides for the use of Prozac in the treatment of major
depressive disorder (MDD) and obsessive compulsive disorder (OCD) in the
pediatric population. |
CASPOFUNGIN ACETATE |
MERCK RES |
21-227 |
SE1 |
007 |
7-Mar-02 |
7-Jan-03 |
|
10.1 |
Provides for the use of Cancidas (caspofungin acetate) For
Injection for the treatment of candidemia and the following Candida
infections: intra-abdominal abscesses, peritonitis and pleural space
infections. |
BUSULFAN |
ORPHAN MEDCL |
20-954 |
SE2 |
004 |
28-Dec-01 |
13-Jan-03 |
Y |
12.5 |
Proposes a change to the package insert for Busulfex (busulfan)
Injection by incorporating pediatric information on dosing, pharmacokinetics
and safety. |
LAMOTRIGINE |
GLAXOSMITHKLINE |
20-241 |
SE1 |
008 |
29-Jan-99 |
17-Jan-03 |
|
47.6 |
Provides for the use of Lamictal (lamotrigine) Tablets as
adjunctive therapy of partial seizures in pediatric patients greater than or
equal to 2 years of age. |
LAMOTRIGINE |
GLAXOSMITHKLINE |
20-764 |
SE1 |
002 |
29-Jan-99 |
17-Jan-03 |
|
47.6 |
Provides for the use of Lamictal (lamotrigine) Chewable
Dispersible Tablets as adjunctive therapy of partial seizures in pediatric
patients greater than or equal to 2 years of age. |
NIACIN |
KOS PHARMS |
20-381 |
SE1 |
013 |
1-Apr-02 |
31-Jan-03 |
|
10.0 |
Provides for the use of Niaspan (niacin extended-release)
Tablets in combination with lovastatin as an adjunct to exercise and diet
for the treatment of adult patients with dyslipidemia. |
SERTRALINE
HYDROCHLORIDE |
PFIZER |
19-839 |
SE1 |
045 |
22-Jan-02 |
7-Feb-03 |
|
12.5 |
Provides for the use of Zoloft (sertraline hydrochloride)
Tablets for the treatment of social anxiety disorder as a new indication. |
SERTRALINE
HYDROCHLORIDE |
PFIZER |
20-990 |
SE1 |
011 |
22-Jan-02 |
7-Feb-03 |
|
12.5 |
Provides for the use of Zoloft (sertraline hydrochloride)
Oral Concentrate for the treatment of social anxiety disorder as a new
indication. |
VENLAFAXINE HYDROCHLORIDE |
WYETH AYERST |
20-699 |
SE1 |
022 |
12-Sep-01 |
11-Feb-03 |
|
17.0 |
Provides for the use of Effexor XR (venlafaxine
hydrochloride) Extended-release Capsules for the treatment of social anxiety
disorder as a new indication. |
POLIFEPROSAN 20 WITH CARMUSTINE |
GUILFORD PHARMS |
20-637 |
SE1 |
016 |
6-Apr-01 |
25-Feb-03 |
Y |
22.7 |
Proposes to expand the indication to include patients with
malignant glioma undergoing primary surgical resection. |
ROSIGLITAZONE MALEATE |
GLAXOSMITHKLINE |
21-071 |
SE1 |
004 |
8-Feb-00 |
27-Feb-03 |
|
36.7 |
Proposes a new indication for the use of Avandia in
combination with insulin for the treatment of patients with Type 2 diabetes
mellitus. |
TECHNETIUM TC99M TETROFOSMIN KIT |
AMERSHAM HLTH |
20-372 |
SE1 |
013 |
29-Apr-02 |
28-Feb-03 |
|
10.0 |
Proposes to expand the indication for Myoview (Kit for the
Preparation of Technetium Tc99m Tetrofosmin for Injection) to include the
assessment of ventricular function in subjects being evaluated for heart
disease and/or ventricular function. |
MOXIFLOXACIN HYDROCHLORIDE |
BAYER |
21-085 |
SE1 |
015 |
18-Dec-02 |
28-Feb-03 |
|
2.4 |
Provides for the modification of the indication for
Community Acquired Pneumonia to add "(including penicillin-resistant
strains, MIC penicillin
> 2μg/mL)" to Streptococcus pneumoniae. |
MOXIFLOXACIN HYDROCHLORIDE |
BAYER |
21-277 |
SE1 |
007 |
18-Dec-02 |
28-Feb-03 |
|
2.4 |
Provides for the modification of the indication for
Community Acquired Pneumonia to add "(including penicillin-resistant
strains, MIC penicillin
> 2μg/mL)" to Streptococcus pneumoniae. |
CONJUGATED ESTROGENS / MEDROXYPROGESTERONE ACETATE |
WYETH AYERST |
20-527 |
SE2 |
017 |
15-Jun-00 |
12-Mar-03 |
|
32.9 |
Provides for the use of PREMPRO (0.45 mg conjugated
estrogen/1.5 mg medroxyprogesterone acetate) in a continuous combined
regimen for: 1. Treatment of moderate to severe vasomotor symptoms
associated with the menopause. 2. Treatment of moderate to severe symptoms
of vulvar and vaginal atrophy associated with the menopause. When
prescribing solely for the treatment of symptoms of vulvar and vaginal
atrophy, topical vaginal products should be considered. |
CEFEPIME
HYDROCHLORIDE |
BRISTOL MYERS SQUIBB |
50-679 |
SE2 |
021 |
22-May-02 |
17-Mar-03 |
|
9.8 |
Provides for labeling revisions for dosing hemodialysis
patients. |
LOSARTAN
POTASSIUM |
MERCK |
20-386 |
SE1 |
032 |
26-Jul-02 |
25-Mar-03 |
Y |
8.0 |
Provides for a new use of Cozaar (losartan potassium) 25, 50
and 100 mg Tablets to reduce the risk of stroke in patients with
hypertension and left ventricular hypertrophy. The Indications section
further notes that there is evidence that this benefit does not apply to
Black patients. |
CARVEDILOL |
GLAXOSMITHKLINE |
20-297 |
SE1 |
009 |
27-Sep-02 |
27-Mar-03 |
Y |
6.0 |
Provides for the use of Coreg (carvedilol) 3.125, 6.25, 12.5
and 25 mg Tablets for the treatment of patients with left ventricular
dysfunction following myocardial infarction. |
VALACYCLOVIR HYDROCHLORIDE |
GLAXOSMITHKLINE |
20-550 |
SE1 |
005 |
24-Apr-97 |
1-Apr-03 |
|
71.3 |
Provides for the use of Valtrex (valacyclovir hydrochloride)
500 mg Caplets for the suppression of recurrent genital herpes in
HIV-infected individuals. |
SIROLIMUS |
WYETH PHARMS INC |
21-083 |
SE1 |
006 |
9-Apr-01 |
11-Apr-03 |
|
24.1 |
Provides for the use of Rapamune (sirolimus) Oral Solution
within an immunosuppressive regimen that would allow for the withdrawal of
cyclosporine 2 to 4 months after renal transplantation in patients
considered at low to moderate immunologic risk for renal transplant
rejection. |
SIROLIMUS |
WYETH PHARMS INC |
21-110 |
SE1 |
004 |
18-Apr-01 |
11-Apr-03 |
|
23.8 |
Provides for the use of Rapamune (sirolimus) Tablets within
an immunosuppressive regimen that would allow for the withdrawal of
cyclosporine 2 to 4 months after renal transplantation in patients
considered at low to moderate immunologic risk for renal transplant
rejection. |
OXYBUTYNIN CHLORIDE |
ALZA |
20-897 |
SE5 |
009 |
7-Dec-01 |
15-Apr-03 |
|
16.2 |
Provides for the use of DITROPAN XL (oxybutynin chloride)
Extended Release Tablets for the treatment of overactive bladder in children
aged six years of age and older. |
SIMVASTATIN |
MERCK |
19-766 |
SE1 |
058 |
19-Jun-02 |
16-Apr-03 |
|
9.9 |
Provides for a new indication, based on the results of the
Heart Protection Study (HPS), for the use of simvastatin in patients at high
risk of coronary events because of existing coronary heart disease,
diabetes, peripheral vessel disease, history of stroke or other
cerebrovascular disease to reduce the risk of total mortality by reducing
coronary death, to reduce the risk of non-fatal myocardial infarction and
stroke, and to reduce the need for coronary and non-coronary
revascularization procedures. In addition, this supplemental application
provides for changes to the CLINICAL PHARMACOLOGY, INDICATIONS AND USAGE,
WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, and DOSAGE AND ADMINISTRATION
sections of the ZOCOR package insert. |
CONJUGATED ESTROGENS, USP |
WYETH PHARMS INC |
04-782 |
SE2 |
115 |
31-Jul-00 |
24-Apr-03 |
|
32.8 |
Provides for the use of Premarin (0.45 mg) for the treatment
of moderate to-severe vasomotor symptoms associated with the menopause and
for the treatment of vulvar and vaginal atrophy associated with the
menopause. When prescribing solely for the treatment of symptoms of vulvar
and vaginal atrophy, topical vaginal products should be considered. Also
provides for revisions in the text of the CLINICAL PHARMACOLOGY, INDICATIONS
AND USAGE, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS,
DOSAGE AND ADMINISTRATION AND HOW SUPPLIED sections of the package insert,
and the text of the patient package insert. |
PIPERACILLIN SODIUM / TAZOBACTAM SODIUM |
WYETH PHARMS INC |
50-684 |
SE2 |
033 |
28-Jun-02 |
28-Apr-03 |
|
10.0 |
Proposes to revise the dosing regimen for nosocomial
pneumonia from 3.375 grams given every 4 hours to 4.5 grams given every 6
hours. |
INSULIN GLARGINE [rDNA ORIGIN] |
AVENTIS PHARMS |
21-081 |
SE2 |
005 |
1-Jul-02 |
1-May-03 |
|
10.0 |
Provides for the change of dosing schedule for Lantus from
once daily at bedtime to flexible dosing. Lantus (insulin glargine [rDNA
origin] injection) is indicated for once daily subcutaneous administration
in the treatment of adult and pediatric patients with type 1 diabetes
mellitus or adult patients with type 2 diabetes mellitus who require basal
(long-acting) insulin for the control of hyperglycemia. |
PIPERACILLIN SODIUM AND TAZOBACTAM SODIUM |
WYETH PHARMS |
50-750 |
SE2 |
008 |
9-Jan-03 |
6-May-03 |
|
3.8 |
Proposes to revise the dosing regimen for nosocomial
pneumonia from 3.375 grams given every 4 hours to 4.5 grams given every 6
hours. |
DOXORUBICIN HYDROCHLORIDE |
PHARMACIA AND UPJOHN |
50-467 |
SE1 |
068 |
8-Apr-02 |
8-May-03 |
|
13.0 |
Provides for the use of Doxorubicin Hydrochloride for
Injection for use in combination with cyclophosphamide as a component of
adjuvant therapy in patients with evidence of axillary node tumor
involvement following resection of primary breast cancer. |
DOXORUBICIN HYDROCHLORIDE |
PHARMACIA AND UPJOHN |
50-629 |
SE1 |
014 |
12-Apr-02 |
8-May-03 |
|
12.9 |
Provides for the use of Doxorubicin Hydrochloride Injection
for use in combination with cyclophosphamide as a component of adjuvant
therapy in patients with evidence of axillary node tumor involvement
following resection of primary breast cancer. |
IMATINIB
MESYLATE |
NOVARTIS |
21-335 |
SE5 |
003 |
28-Jun-02 |
20-May-03 |
Y |
10.7 |
Provides for the use of Gleevec (imatinib mesylate) Tablets
for the treatment of pediatric patients with Ph+ chronic phase CML whose
disease has recurred after stem cell transplant or who are resistant to
interferon alpha therapy. There are no controlled trials demonstrating a
clinical benefit, such as improvement in disease-related symptoms or
increased survival. |
IMATINIB
MESYLATE |
NOVARTIS |
21-588 |
SE5 |
001 |
24-Apr-03 |
20-May-03 |
Y |
0.9 |
Provides for the use of Gleevec (imatinib mesylate) Tablets
for the treatment of pediatric patients with Ph+ chronic phase CML whose
disease has recurred after stem cell transplant or who are resistant to
interferon alpha therapy. There are no controlled trials demonstrating a
clinical benefit, such as improvement in disease-related symptoms or
increased survival. |
FENTANYL |
ALZA |
19-813 |
SE1 |
036 |
26-Nov-02 |
20-May-03 |
Y |
5.8 |
Provides for the use of Duragesic (Fentanyl Transdermal
System) in opioid-telerant pediatric patients 2 years of age and older. |
LEVOFLOXACIN |
ORTHO MCNEIL PHARM |
20-634 |
SE1 |
027 |
29-Jul-02 |
23-May-03 |
|
9.8 |
Provides for the use of Levaquin Tablets for the treatment
of chronic bacterial prostatitis. |
LEVOFLOXACIN |
ORTHO MCNEIL PHARM |
20-635 |
SE1 |
026 |
29-Jul-02 |
23-May-03 |
|
9.8 |
Provides for the use of Levaquin Injection for the treatment
of chronic bacterial prostatitis. |
FOSINOPRIL SODIUM |
BRISTOL MYERS SQUIBB |
19-915 |
SE5 |
037 |
27-Nov-02 |
27-May-03 |
Y |
6.0 |
Proposes changes to the CLINICAL PHARMACOLOGY, PRECAUTIONS,
ADVERSE REACTIONS, OVERDOSAGE, and DOSAGE AND ADMINISTRATION sections of the
labeling concerning the use of Monopril in pediatric patients. |
FLUVASTATIN SODIUM |
NOVARTIS |
20-261 |
SE1 |
033 |
1-Aug-02 |
27-May-03 |
|
9.8 |
Provides for a new indication, based on the results of the
Lescol Intervention Prevention Study (LIPS), for the use of fluvastatin in
patients with coronary heart disease to reduce the risk of undergoing
coronary revascularization procedures. In addition, this supplemental
application provides for changes to the CLINICAL PHARMACOLOGY, INDICATIONS
AND USAGE, and ADVERSE REACTIONS sections of the LESCOL package insert. |
FLUVASTATIN SODIUM |
NOVARTIS |
21-192 |
SE1 |
005 |
1-Aug-02 |
27-May-03 |
|
9.8 |
Provides for a new indication, based on the results of the
Lescol Intervention Prevention Study (LIPS), for the use of fluvastatin in
patients with coronary heart disease to reduce the risk of undergoing
coronary revascularization procedures. In addition, this supplemental
application provides for changes to the CLINICAL PHARMACOLOGY, INDICATIONS
AND USAGE, and ADVERSE REACTIONS sections of the LESCOL XL package insert. |
LISINOPRIL |
MERCK |
19-558 |
SE5 |
043 |
25-Sep-01 |
29-May-03 |
|
20.1 |
Proposes changes to the CLINICAL PHARMACOLOGY, WARNINGS,
PRECAUTIONS, ADVERSE REACTIONS, and DOSAGE AND ADMINISTRATION sections of
the labeling concerning the use of Prinivil (lisinopril) in pediatric
patients. |
IRON
SUCROSE |
LUITPOLD |
21-135 |
SE2 |
006 |
2-Aug-02 |
2-Jun-03 |
|
10.0 |
Provides additional safety information for the use of
Venofer for the treatment of iron deficiency anemia in patients undergoing
chronic hemodialysis who are receiving supplemental erythropoietin therapy. |
CONJUGATED ESTROGENS / MEDROXYPROGESTERONE ACETATE |
WYETH PHARMS |
20-527 |
SE1 |
024 |
7-Nov-01 |
4-Jun-03 |
|
18.9 |
Provides for an additional strength of PREMPRO (0.3 mg
conjugated estrogens / 1.5 mg medroxyprogesterone acetate) continuous
combined regimen for the treatment of moderate-to-severe vasomotor symptoms
associated with the menopause, and the treatment of moderate to severe
symptoms of vulvar and vaginal atrophy associated with the menopause. When
prescribing solely for the treatment of symptoms of vulvar and vaginal
atrophy, tropical vaginal products should be considered. |
LEFLUNOMIDE |
AVENTIS PHARMS |
20-905 |
SE1 |
006 |
31-Aug-00 |
13-Jun-03 |
Y |
33.4 |
Provides for the use of Arava (leflunomide) tablets, for
rheumatoid arthritis. Specifically, the supplemental NDA S-006 provides for
revised labeling to support the addition of a claim for improved physical
function. |
FONDAPARINUX SODIUM |
FONDA BV |
21-345 |
SE1 |
002 |
17-Dec-02 |
17-Jun-03 |
Y |
6.0 |
Provides for the use of Arixtra (fondaparinux sodium)
injection for extended prophylaxis in patients undergoing hip fracture
surgery. |
ATROPINE |
MERIDIAN MEDCL TECHN |
17-106 |
SE5 |
028 |
27-Dec-02 |
19-Jun-03 |
Y |
5.7 |
Provides for use of the AtroPen Autoinjector in pediatric
populations and includes information to support two lower strength AtroPen
autoinjectors (0.5 mg and 1 mg) and a revised package insert for use in both
adult and pediatric populations. |
LAMOTRIGINE |
GLAXOSMITHKLINE |
20-241 |
SE1 |
017 |
6-Jun-02 |
20-Jun-03 |
|
12.5 |
Provides for the use of Lamictal (lamotrigine) Tablets for
the maintenance treatment of Bipolar I Disorder to delay the time to
occurrence of mood episodes (depression, mania, hypomania, mixed episodes)
in patients treated for acute mood episodes with standard therapy. |
LAMOTRIGINE |
GLAXOSMITHKLINE |
20-764 |
SE1 |
011 |
6-Jun-02 |
20-Jun-03 |
|
12.5 |
Provides for the use of Lamictal (lamotrigine) Chewable
Dispersible Tablets for the maintenance treatment of Bipolar I Disorder to
delay the time to occurrence of mood episodes (depression, mania, hypomania,
mixed episodes) in patients treated for acute mood episodes with standard
therapy. |
HYDROXYUREA |
BRISTOL MYERS SQUIBB |
16-295 |
SE2 |
036 |
27-Aug-02 |
26-Jun-03 |
|
10.0 |
Provides for revisions to the labeling based on data
obtained from a Phase 4 commitment study to determine the influence of renal
impairment on the pharmacokinetics of hydroxyurea in adults with sickle cell
disease. |
FORMOTEROL FUMARATE |
NOVARTIS |
20-831 |
SE5 |
005 |
28-Aug-02 |
27-Jun-03 |
|
10.0 |
Provides for the use of Foradil Aerolizer (formoterol
fumarate) Inhalation Powder for the prevention of EIB in children 5 years
old and older. |
LISINOPRIL |
ASTRAZENECA |
19-777 |
SE5 |
044 |
5-Nov-01 |
1-Jul-03 |
|
19.8 |
Proposes changes in the CLINICAL PHARMACOLOGY, INDICATIONS
AND USAGE, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS,
OVERDOSAGE and DOSAGE AND ADMINISTRATION sections of the labeling concerning
the use of Zestril (lisinopril) in pediatric patients and revised safety
information. |
OLANZAPINE |
LILLY |
20-592 |
SE1 |
018 |
17-Sep-02 |
10-Jul-03 |
|
9.7 |
Provides for the use of olanzapine in combination with
lithium or valproate for the treatment of acute manic episodes associated
with bipolar disorder. |
CONJUGATED
ESTROGENS |
WYETH PHARMS |
21-417 |
N |
000 |
18-Dec-01 |
16-Jul-03 |
|
18.9 |
Provides for the use of Premarin (conjugated estrogens
tablets, USP) 0.3 gm and 0.45 mg for the prevention of postmenopausal
osteoporosis. |
SOMATROPIN [rDNA ORIGIN] |
LILLY |
19-640 |
SE1 |
033 |
26-Sep-02 |
25-Jul-03 |
|
9.9 |
Provides for the use of Humatrope for the long-term
treatment of idiopathic short stature, also called non-growth
hormone-deficient short stature, defined by height SDS < -2.25, and associated
with growth rates unlikely to permit attainment of adult height in the
normal range, in pediatric patients whose epiphyses are not closed and for
whom diagnostic evaluation excludes other causes associated with short
stature that should be observed or treated by other means. |
GEMIFLOXACIN MESYLATE |
GENESOFT PHARMS |
21-158 |
SE1 |
001 |
4-Jun-03 |
25-Jul-03 |
|
1.7 |
Provides for the use of Factive (gemifloxacin mesylate)
Tablets for community-acquired pneumonia caused by Streptococcus pneumoniae
including multi-drug resistant Streptococcus pneumoniae (MDRSP) strains. |
PORFIMER
SODIUM |
AXCAN SCANDIPHARM |
21-525 |
N |
000 |
31-May-02 |
1-Aug-03 |
Y |
14.0 |
Provides for the use of PHOTOFRIN (porfimer sodium) for
Injection for the ablation of high-grade dysplasia in Barrett's esophagus
patients who do not undergo esophagectomy. |
OXCARBAZEPINE |
NOVARTIS |
21-014 |
SE5 |
003 |
12-Feb-01 |
7-Aug-03 |
|
29.8 |
Provides for the use of Trileptal as monotherapy in the
treatment of partial seizures in children ages 4-16. |
DIVALPROEX
SODIUM |
ABBOTT |
21-168 |
SE5 |
007 |
14-Feb-03 |
14-Aug-03 |
Y |
6.0 |
Provides for the use of Depakote ER (divalproex) tablets in
pediatric patients for epilepsy. |
TENOFOVIR
DISOPROXIL FUMARATE |
GILEAD |
21-356 |
SE5 |
003 |
15-Oct-02 |
15-Aug-03 |
|
10.0 |
Provides for the use of VIREAD (tenofovir disoproxil
fumarate) 300mg Tablets in combination with other antiretroviral agents for
the treatment of HIV-1 infection. |
PAROXETINE
HYDROCHLORIDE |
GLAXOSMITHKLINE |
20-936 |
SE1 |
011 |
26-Jun-02 |
28-Aug-03 |
|
14.1 |
Provides for the use of Paxil CR in the treatment of
premenstrual dysphoric disorder (PMDD). |
ARIPIPRAZOLE |
OTSUKA |
21-436 |
SE1 |
001 |
4-Dec-02 |
28-Aug-03 |
|
8.8 |
Provides for the longer-term efficacy of aripiprazole in the
treatment of schizophrenia. |
CIPROFLOXACIN |
BAYER |
21-554 |
N |
000 |
29-Oct-02 |
28-Aug-03 |
|
10.0 |
Provides for the use of CIPRO XR (ciprofloxacin extended
release tablets) for complicated urinary tract infections and acute
uncomplicated pyelonephritis. |
SOMATROPIN |
SERONO |
20-604 |
SE7 |
027 |
1-Nov-02 |
29-Aug-03 |
|
9.9 |
Provides for the use of Serostim [somatropin (rDNA origin)
for injection] for HIV patients with wasting or cachexia to increase lean
body mass and body weight, and improve physical endurance. |
VALACYCLOVIR HYDROCHLORIDE |
GLAXOSMITHKLINE |
20-550 |
SE1 |
019 |
1-Nov-02 |
29-Aug-03 |
|
9.9 |
Provides for the use of Valtrex (valacyclovir hydrochloride)
500 mg Caplets in combination with safer sex practices for the reduction of
the risk of transmission of genital herpes during suppressive therapy of the
source partner in a heterosexual couple. |
VALGANCICLOVIR HYDROCHLORIDE |
ROCHE PALO |
21-304 |
SE1 |
001 |
12-Nov-02 |
12-Sep-03 |
|
10.0 |
Provides for the use of Valcyte (valganciclovir
hydrochloride) 450 mg Tablets for the prevention of cytomegalovirus (CMV)
disease in kidney, heart, and kidney-pancreas transplant patients at high
risk (Donor CMV seropositive/Recipient CMV seronegative). |
SERTRALINE HYDROCHLORIDE |
PFIZER |
19-839 |
SE5 |
044 |
17-Dec-01 |
16-Sep-03 |
|
21.0 |
Provides for additional safety data in the pediatric
population. |
SERTRALINE HYDROCHLORIDE |
PFIZER |
20-990 |
SE5 |
010 |
17-Dec-01 |
16-Sep-03 |
|
21.0 |
Provides for additional safety data in the pediatric
population. |
FAMOTIDINE |
MERCK |
20-325 |
SE2 |
015 |
22-Nov-02 |
23-Sep-03 |
|
10.0 |
Provides for a 20 mg nonprescription famotidine tablet. |
LOSARTAN
POTASSIUM / HYDROCHLOROTHIAZIDE |
MERCK |
20-387 |
SE1 |
027 |
25-Sep-02 |
30-Sep-03 |
|
12.2 |
Provides for a new use of Hyzaar (losartan
potassium/hydrochlorothiazide) 50-12.5 and 100-25 mg Tablets in the
treatment of hypertension. This fixed dose combination is not indicated for
initial therapy of hypertension, except when the hypertension is severe
enough that the value of achieving prompt blood pressure control exceeds the
risk of initiating combination therapy in these patients. In addition, this
supplement provides for revisions to the DESCRIPTION, CLINICAL PHARMACOLOGY,
ADVERSE REACTIONS, and DOSAGE AND ADMINISTRATION sections of the labeling. |
OFLOXACIN |
DAIICHI |
20-799 |
SE2 |
006 |
29-Jan-01 |
30-Sep-03 |
|
32.0 |
Proposes once-a-day dosing of FLOXIN Otic for the treatment
of adults and pediatric patients (ages 6 months and older) with Otitis
Externa (OE) caused by susceptible strains of Escherichia coli, Pseudomonas
aeruginosa, and Staphylococcus aureus. |
EPLERENONE |
GD SEARLE LLC |
21-437 |
SE1 |
002 |
7-Apr-03 |
7-Oct-03 |
Y |
6.0 |
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 |
20-629 |
SE5 |
008 |
11-Dec-02 |
10-Oct-03 |
|
10.0 |
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 |
20-936 |
SE1 |
012 |
20-Dec-02 |
16-Oct-03 |
|
9.9 |
Provides for the use of Paxil CR (paroxetine hydrochloride)
Controlled-release Tablets for the treatment of social anxiety disorder as a
new indication. |
NATEGLINIDE |
NOVARTIS |
21-204 |
SE1 |
006 |
20-Dec-02 |
20-Oct-03 |
|
10.0 |
Provides for an expanded indication for the use of Starlix (nateglinide)
Tablets, in combination with antidiabetic drugs in the thiazolidinedione
class. |
LEVOFLOXACIN |
ORTHO MCNEIL PHARM |
20-634 |
SE2 |
028 |
23-Dec-02 |
23-Oct-03 |
|
10.0 |
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. |
LEVOFLOXACIN |
ORTHO MCNEIL PHARM |
20-635 |
SE2 |
027 |
23-Dec-02 |
23-Oct-03 |
|
10.0 |
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. |
VORICONAZOLE |
PFIZER GLOBAL |
21-464 |
N |
000 |
17-Nov-00 |
14-Nov-03 |
|
35.9 |
Provides for the use of VFEND (voriconazole) Tablets for
esophageal candidiasis. |
VORICONAZOLE |
PFIZER GLOBAL |
21-466 |
N |
000 |
17-Nov-00 |
14-Nov-03 |
|
35.9 |
Provides for the use of VFEND (voriconazole for injection)
I.V. for esophageal candidiasis. |
SALMETEROL
XINAFOATE / FLUTICASONE PROPIONATE |
GLAXOSMITHKLINE |
21-077 |
SE1 |
003 |
7-May-01 |
17-Nov-03 |
|
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 |
19-658 |
SE6 |
020 |
28-Jan-02 |
19-Nov-03 |
|
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. |
LORATADINE |
SCHERING |
20-641 |
SE6 |
011 |
28-Jan-02 |
19-Nov-03 |
|
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 |
20-704 |
SE6 |
009 |
28-Jan-02 |
19-Nov-03 |
|
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. |
SOMATOTROPIN (RDNA ORIGIN) |
SERONO INC |
21-597 |
N |
000 |
1-Nov-02 |
1-Dec-03 |
|
13.0 |
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
AND PROGUANIL HYDROCHLORIDE |
GLAXOSMITHKLINE |
21-078 |
SE5 |
006 |
2-Jun-03 |
2-Dec-03 |
Y |
6.0 |
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 PHARMA |
20-272 |
SE1 |
026 |
16-Dec-02 |
4-Dec-03 |
|
11.6 |
Provides for Monotherapy - for short term treatment of acute
manic or mixed episodes associated with Bipolar I Disorder |
RISPERIDONE |
JANSSEN PHARMA |
20-272 |
SE1 |
027 |
16-Dec-02 |
4-Dec-03 |
|
11.6 |
Provides for Adjunctive Therapy - for short term treatment
of acute manic or mixed episodes associated with Bipolar I Disorder |
RISPERIDONE |
JANSSEN PHARM |
20-588 |
SE1 |
017 |
16-Dec-02 |
4-Dec-03 |
|
11.6 |
Provides for Monotherapy - for short term treatment of acute
manic or mixed episodes associated with Bipolar I Disorder |
RISPERIDONE |
JANSSEN PHARM |
20-588 |
SE1 |
018 |
16-Dec-02 |
4-Dec-03 |
|
11.6 |
Provides for Adjunctive Therapy - for short term treatment
of acute manic or mixed episodes associated with Bipolar I Disorder |
RISPERIDONE |
JOHNSON AND JOHNSON |
21-444 |
SE1 |
002 |
15-Aug-03 |
4-Dec-03 |
|
3.6 |
Provides for Monotherapy - for short term treatment of acute
manic or mixed episodes associated with Bipolar I Disorder |
RISPERIDONE |
JOHNSON AND JOHNSON |
21-444 |
SE1 |
003 |
15-Aug-03 |
4-Dec-03 |
|
3.6 |
Provides for Adjunctive Therapy - for short term treatment
of acute manic or mixed episodes associated with Bipolar I Disorder |
IMATINIB
MESYLATE |
NOVARTIS PHARMS |
21-588 |
SE7 |
002 |
28-Aug-03 |
8-Dec-03 |
|
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-alpha therapy. |
DALTEPARIN
SODIUM |
PHARMACIA AND UPJOHN |
20-287 |
SE1 |
032 |
10-Feb-03 |
10-Dec-03 |
|
10.0 |
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 medical patients who are at risk for
thromboembolic complications due to severely restricted mobility during
acute illness. |
ORLISTAT |
HOFFMANN-LAROCHE |
20-766 |
SE5 |
018 |
24-Jun-03 |
12-Dec-03 |
Y |
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 PHARM |
20-505 |
SE2 |
017 |
1-Jul-02 |
16-Dec-03 |
|
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 |
20-844 |
SE2 |
014 |
1-Jul-02 |
16-Dec-03 |
|
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 LABS |
21-323 |
SE1 |
003 |
27-Nov-02 |
18-Dec-03 |
|
12.7 |
Provides for the treatment of generalized anxiety disorder. |
ESCITALOPRAM OXALATE |
FOREST LABS |
21-365 |
SE1 |
004 |
22-May-03 |
18-Dec-03 |
|
6.9 |
Provides for the treatment of generalized anxiety disorder. |
SAQUINAVIR
MESYLATE |
HOFFMANN-LAROCHE |
20-628 |
SE2 |
020 |
24-Feb-03 |
24-Dec-03 |
|
10.0 |
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
MESYLATE |
HOFFMANN-LAROCHE |
20-828 |
SE2 |
015 |
24-Feb-03 |
24-Dec-03 |
|
10.0 |
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. |