Mylan Wins FDA Nod for Generic Copaxone

Mylan (NASDAQ: MYL) shares soared Wednesday after it said the U.S. Food and Drug Administration approved its generic version of Teva Pharmaceutical's multiple sclerosis treatment Copaxone.
Mylan, whose stock was down 14% this year as of Tuesday's close, said that shipping was imminent for its Glatiramer Acetate 40 mg/mL for 3-times-a-week injection and 20 mg/mL for once-daily injection.
MS is a chronic disease of the central nervous system and afflicts an estimated 400,000 Americans.
The approvals "mark another significant milestone for our company, reinforce our proven capabilities in bringing complex and difficult-to-manufacture products to market, and further our commitment to providing access to high-quality medicines," Mylan CEO Heather Bresch said in a press release.
The FDA on Monday said it would introduce new measures to speed up bringing generic versions of complex drugs to the market. The moves came as the agency attempts to deal with the rising cost of drugs in the U.S.
In addition, Mylan is introducing Mylan MS AdvocateTM, a comprehensive patient support service program to help patients get started on and stay on track with their physician's treatment plan for either dose strength of Mylan's Glatiramer Acetate Injection.
Copaxone® is the most prescribed MS treatment for relapsing forms of MS in the United States.
Approximately 400,000 individuals in the U.S. have MS and relapsing MS accounts for 85% of initial MS diagnoses.
Mylan shares thrived $6.42, or 19.7%, to $38.95, in mid-morning trade on Wednesday.