FDA of­fers sur­prise OK for My­lan’s Co­pax­one knock­offs, slam­ming Te­va

My­lan won its years-long quest to gain an FDA OK for its copy­cat of Te­va’s 40 mg and 20 mg dos­es of the mul­ti­ple scle­ro­sis drug Co­pax­one, trig­ger­ing a se­ries of stock moves as in­vestors re­act­ed quick­ly to the un­ex­pect­ed ad­vance.

My­lan had been de­layed by in­for­ma­tion re­quests from the FDA, which prompt­ed some an­a­lysts ear­li­er to write off any pos­si­bil­i­ty of an OK this year. But FDA com­mis­sion­er Scott Got­tlieb has made swifter gener­ic ap­provals — with the im­plic­it promise of low­er drug prices — a top pri­or­i­ty at the agency.

Endpoints News

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.