Withdrawal of generic budeprion for nonbioequivalence
N Engl J Med
.
2012 Dec 27;367(26):2463-5.
doi: 10.1056/NEJMp1212969.
Epub 2012 Dec 5.
Authors
Janet Woodcock
1
,
Mansoor Khan
,
Lawrence X Yu
Affiliation
1
Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, MD, USA.
PMID:
23216549
DOI:
10.1056/NEJMp1212969
No abstract available
MeSH terms
Area Under Curve
Bupropion / pharmacokinetics*
Drug Approval
Drugs, Generic / pharmacokinetics*
Humans
Safety-Based Drug Withdrawals*
Therapeutic Equivalency*
United States
United States Food and Drug Administration
Substances
Drugs, Generic
Bupropion