|
[Logo CDER] CHEMISTRY REVIEW
TEMPLATE [Logo CDER] |
Chemistry Assessment Section
ONDC:
|
CONSULTS/CMC RELATED
REVIEWS |
RECOMMENDATION |
DATE |
REVIEWER |
|
Biometrics |
N/A |
N/A |
N/A |
|
EES |
Acceptable |
4/21/03 |
Office
of Compliance |
|
Pharm/Tox |
N/A |
N/A |
N/A |
|
Biopharm |
Acceptable
pending outcome of DSI inspection |
5/12/03 |
Sally
Yasuda |
|
Methods
Validation |
Pending |
Pending |
Sherita
McLamore, Ph.D. |
|
DMETS |
Acceptable |
5/9/03 |
Jennifer
Fan, Pharm.D. |
|
EA |
Categorical
Exclusion Granted |
5/25/05 |
Sherita
McLamore, Ph.D. |
|
Microbiology |
N/A |
N/A |
N/A |
The Chemistry Review for NDA
21-515
The
Executive Summary
I.
Recommendations
A.
Recommendation and Conclusion on Approvability
The Chemistry, Manufacturing, and Controls (CMC) section of NDA 21-515 is complete has been approved.
Methods
validation will be submitted.
B.
Recommendation on Phase 4 (Post-Marketing) Commitments, Agreements,
and/or Risk Management Steps, if Approvable
N/A
II. Summary of Chemistry Assessments
A.
Description of the Drug Product(s) and Drug Substance(s)
Bupropion Hydrochloride was originally investigated
under IND 13, 845. Bupropion is a
racemate and is a member of the aminoketone class of compounds. Bupropion Hydrochloride is currently
approved for use in Welbutrin [Wellbutrin] SRŪ
Tablets (NDA 20-358) and the Wellbutrin Tablets (NDA 18-644). The applicant included very limited
information on the drug substance in this application and references [blacked
out] for the manufacture and controls of
Page 6 of 10
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