Reference Listed Drug Labeling
and Efficacy
Supplements Approved in February 2002
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| Approval
Date |
Product Name |
|
|
Active
Ingredient(s) |
Dosage Form |
NDA No |
Supp No |
| |
GLEEVEC
|
letter |
label |
imatinib mesylate
|
capsule |
21-335 |
SE1 001 |
| Feb 1 |
Efficacy Claim: For the treatment of patients
with Kit (CD117) positive unresectable and/or metastatic malignant
gastrointestinal stromal tumors (GIST) |
| |
MINOCIN
|
letter |
|
minocycline HCl
|
capsule |
50-649 |
S- 007 |
| |
MINOCIN
|
letter |
|
minocycline HCl
|
oral suspension |
50-445 |
S- 017 |
| |
ROCALTROL
|
letter |
label |
calcitriol
|
capsule |
21-068 |
S-001 |
| |
ROCALTROL
|
letter |
label |
calcitriol
|
oral solution |
18-044 |
S-028 |
| |
AKINETON
|
letter |
|
biperiden
|
tablet |
12-003 |
S-024 |
| Feb 4 |
MOTRIN
|
letter |
|
ibuprofen
|
oral drops |
20-476 |
S-002 |
| |
MOTRIN
|
letter |
|
ibuprofen
|
tablet |
20-135 |
S-005 |
| |
MOTRIN
|
letter |
|
ibuprofen
|
oral suspension |
19-842 |
S-013 |
| |
AGENERASE
|
letter |
label |
amprenavir
|
capsule |
21-039 |
SE8 009 |
| |
Efficacy Claim: For the co-administration
with Norvir (ritonavir) in the treatment of HIV-! infection |
| Feb 5 |
AGENERASE
|
letter |
label |
amprenavir
|
oral solution |
21-007 |
SE8 010 |
| |
Efficacy Claim: For the co-administration
with Norvir (ritonavir) in the treatment of HIV-! infection |
| |
ETHAMOLIN
|
letter |
|
ethanolamine oleate
|
injection |
19-357 |
S-014 |
| |
INNOHEP
|
letter |
|
tinazaparin Na
|
injection |
20-484 |
S-002 |
| |
TRIZIVIR
|
letter |
label |
abacavir sulfate / lamivudine/zidovudine
|
tablet |
21-205 |
SE8 002 |
| |
Efficacy
Claim: incorporate appropriate changes into the labeling that have
recently been approved for Ziagen and Retrovir products. |
| |
VIRACEPT
|
letter |
label |
nelfinavir mesylate
|
tablet |
20-779 |
S-038 |
| |
VIRACEPT
|
letter |
label |
nelfinavir mesylate
|
oral powder |
20-778 |
S-017 |
| |
ZOLADEX 3-month
|
letter |
label |
goserelin acetate
|
implant |
20-578 |
S-013 |
| |
ZOLADEX 3.6 mg
|
letter |
label |
goserelin acetate
|
implant |
19-726 |
S-034 |
| Feb 6 |
MIRADON
|
letter |
label |
anisindione
|
tablet |
10-909 |
S-013 |
| |
BUSPAR
|
letter |
label |
buspirone HCl
|
tablet |
18-731 |
S-046 |
| Feb 7 |
TRANXENE SD
|
letter |
|
clorazepate dipotassium
|
tablet |
17-105 |
S-062 |
| |
VALIUM
|
letter |
|
diazepam
|
tablet |
13-263 |
S-075 |
| |
VALIUM
|
letter |
|
diazepam
|
injection |
16-087 |
S-081 |
| |
ACULAR
|
letter |
label |
ketorolac tromethamine
|
ophthalmic sol |
19-700 |
SE5 019 |
| |
Efficacy Claim:For the temporary relief of
ocular itching due to seasonal allergic conjunctivitis; for the treatment of
postoperative inflammation in patients who have undergone cataract extraction |
| Feb 8 |
ACULAR PF
|
letter |
label |
ketorolac tromethamine
|
ophthalmic sol |
20-811 |
SE5 003 |
| |
Efficacy Claim:For the temporary relief of
ocular itching due to seasonal allergic conjunctivitis; for the treatment of
postoperative inflammation in patients who have undergone cataract extraction |
| |
CAFCIT
|
letter |
label |
caffeine citrate
|
injection |
20-793 |
S-004 |
| |
CLARINEX
|
letter |
label |
desloratidine
|
tablet |
21-165 |
S-001 |
| |
BUPRENEX
|
letter |
label |
buprenorphine HCl
|
injection |
18-401 |
S-014 |
| Feb 11 |
NARCAN
|
letter |
label |
naloxone HCl
|
injection |
16-636 |
S-054 |
| |
PREMPRO
|
letter |
|
conjugated estrogens/ medroxyprogesterone
|
tablet |
20-527 |
S-018 |
| |
ACIPHEX
|
letter |
label |
rabeprazole Na
|
delayed-release tablet |
20-973 |
SE1 009 |
| |
Efficacy Claim:For the treatment of
symptomatic gastrointestinal reflux disease (GERD) |
| Feb 12 |
LEUCOVORIN
|
letter |
|
leucovorin Ca
|
injection |
08-107 |
S-054 |
| |
PAXIL
|
letter |
label |
paroxetine HCl
|
tablet |
20-936 |
S-008 |
| |
DESFERAL
|
letter |
label |
deferoxamine mesylate
|
injection |
16-267 |
S-039 |
| Feb 14 |
MEVACOR
|
letter |
label |
lovastatin
|
tablet |
19-643 |
SE5 067 |
| |
Efficacy Claim: For the treatment of
heterozygous familial hypercholesterolemia in a new population of adolescent
boys and girls at leat one year postmenarchal, ages 10 to 17 years, with a
recommended dosing range of 10 to 40 mg once daily |
| |
PARAPLATIN
|
letter |
label |
carboplatin
|
injection |
19-880 |
S-011 |
| |
PRILOSEC
|
letter |
|
omeprazole
|
delayed-release capsule |
19-810 |
SE8 061 |
| |
Efficacy Claim: For the short-term treatment
of active duodenal ulcer |
| Feb 15 |
ACCUTANE
|
letter |
label |
isotretinoin
|
capsule |
18-662 |
S-046 |
| |
GEODON
|
letter |
|
ziprasidone
|
capsule |
20-825 |
S-006 |
| |
ETHYOL
|
letter |
|
amifostine
|
injection |
20-221 |
S-015 |
| Feb 20 |
METHOTREXATE
|
letter |
|
methotrexate
|
tablet |
11-719 |
S-103 |
| |
METHOTREXATE
|
letter |
|
methotrexate
|
injection |
08-085 |
S-054 |
| |
NOVANTRONE
|
letter |
|
mitoxantrone
|
injection |
19-297 |
S-024 |
| |
VIROPTIC
|
letter |
label |
trifluridine
|
ophthalmic sol |
18-299 |
S-014 |
| |
ZERIT
|
letter |
|
stavudine
|
capsule |
20-412 |
S-018 |
| |
ZERIT
|
letter |
|
stavudine
|
oral solution |
20-413 |
S-009 |
| |
DAUNOXOME
|
letter |
|
daunorubicin citrate liposome
|
injection |
50-704 |
S-008 |
| Feb 21 |
DEFINITY
|
letter |
|
perflutren lipid microsphere
|
injection |
21-064 |
S-001 |
| |
ETOPOPHOS
|
letter |
|
etoposide phosphate
|
injection |
20-457 |
S-003 |
| |
REBETOL
|
letter |
label |
ribavirin
|
capsule |
20-903 |
S-015 |
| |
RETROVIR
|
letter |
label |
zidovudine
|
capsule |
19-655 |
S-037 |
| |
RETROVIR
|
letter |
label |
zidovudine
|
syrup |
20-518 |
S-009 |
| |
RETROVIR
|
letter |
label |
zidovudine
|
tablet |
19-951 |
S-017 |
| |
ZYBAN
|
letter |
|
bupropion HCl
|
extended-release tablet |
20-711 |
S-015 |
| |
CENESTIN
|
letter |
|
synthetic conjugated estrogens
|
tablet |
20-992 |
S-011 |
| Feb 22 |
PROCARDIA
|
letter |
|
nifedipine
|
capsule |
18-482 |
S-043 |
| |
ZOMETA
|
letter |
label |
zoledronic acid
|
injection |
21-223 |
S-003 |
| Feb 27 |
PLAVIX
|
letter |
|
clopidrogrel bisulfate
|
tablet |
20-839 |
SE1 019 |
| |
Efficacy Claim: For
use in Acute Coronary Syndrome. |
| |
MALARONE
|
letter |
label |
atovaquone/proguanil HCl
|
tablet |
21-078 |
S-001 |
| Feb 28 |
SPORANOX
|
letter |
label |
itraconazole
|
injection |
20-966 |
S-005 |
| |
ZOLADEX 3-month
|
letter |
|
goserelin acetate
|
implant |
20-578 |
S-016 |
| |
ZOLADEX 3.6 mg
|
letter |
|
goserelin acetate
|
implant |
19-726 |
S-037 |
