Withdrawal of generic budeprion for nonbioequivalence

New England Journal of Medicine

Volumn 367, Issue 26, 2012, Pages 2463-2465

  Woodcock, Janet ^a   Khan, Mansoor ^a   Yu, Lawrence X ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AMFEBUTAMONE; GENERIC DRUG;

AREA UNDER THE CURVE; BIOEQUIVALENCE; DIET RESTRICTION; DRUG ABSORPTION; DRUG APPROVAL; DRUG BLOOD LEVEL; DRUG EFFICACY; DRUG INDUSTRY; DRUG INFORMATION; DRUG MANUFACTURE; DRUG MARKETING; DRUG QUALITY; DRUG RECALL; DRUG RESEARCH; DRUG SAFETY; DRUG SUBSTITUTION; DRUG WITHDRAWAL; FOOD AND DRUG ADMINISTRATION; HUMAN; MAJOR DEPRESSION; MASS MEDIUM; MAXIMUM PLASMA CONCENTRATION; MEDICAL RESEARCH; METHODOLOGY; PRIORITY JOURNAL; SAMPLE SIZE; SEIZURE; SHORT SURVEY; SINGLE DRUG DOSE; SUSTAINED RELEASE FORMULATION; TIME TO MAXIMUM PLASMA CONCENTRATION; UNSPECIFIED SIDE EFFECT; VOLUNTEER;

EID: 84871703418     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMp1212969     Document Type: Article

References (1)

1. Guidance for industry: bioavailability and bioequivalence studies for orally administered drug products - general considerations. Washington, DC: Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), 2003 (http://www.fda.gov/downloads/ Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070124.pdf).