Enforcement Report - Week of March 25, 2020
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 21 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Beximco Pharms 's Generic Sotalol Hydrochloride Receives Approval in US
Beximco's Generic Sotalol Hydrochloride Receives Approval In US
Anvisa approved on Friday (30/09) the list of candidate drugs to bioisenção based on Biopharmaceutics Classification System (BCS). . Generic drugs, similar or new, oral immediate release, containing the list of drugs, may be candidates for bioisenção based biopharmaceutical classification system