Mylan gets FDA's nod for sclerosis drug

Hyderabad: Hyderabad-based Pharma company Natco Pharma said its marketing partner Mylan has received approval from the United States Food and Drug Administration (FDA) for the generic version of multiple sclerosis drug — Copaxone — of Teva Pharmaceuticals. Natco’s shares, hit the upper circuit of 20 per cent (Rs 954.35) a piece on BSE on Wednesday after the news reached the market.

“The launch plans for both products will be communicated shortly after concurring with its partner Mylan,” Natco said. According to the FDA approval letter, Mylan was one of the first applicants to submit a substantially complete ANDA for Glatiramer Acetate Injection, 40 mg/ml, containing a paragraph IV certification. “Therefore, Mylan and other first filers may be eligible for 180 days of generic drug exclusivity but FDA has not made a formal determination on exclusivity at this time,” Mylan said. In 2015, the US Court of Appeals had found that one of the patents was invalid.