-
Court blocks Apotex's generic Paxil CR
PITTSBURGH A U.S. District Court has blocked Canadian generic drug maker Apotex from selling generic versions of an antidepressant drug.
Generic drug maker Mylan said Tuesday that it had obtained a temporary restraining order from the U.S. District Court for the District of New Jersey prohibiting Apotex from selling generic versions of the drug Paxil CR (paroxetine hydrochloride), an extended-release formulation of GlaxoSmithKline’s Paxil.
-
Report: FDA hearing to discuss biosimilar regulations
WASHINGTON The Food and Drug Administration is looking for input on regulations concerning knock-off versions of biotech drugs, according to published reports.
The Hill, a newspaper in Washington, reported Monday that the FDA would have a hearing on Nov. 2 and 3 concerning follow-on biologics, based on a draft document distributed to healthcare lobbyists.
According to the report, the hearing would focus on such issues as interchangeability and definitions of such terms as “biological product.”