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.
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