An Abbreviated New Drug Application (ANDA) for tbree-times-a-week generic Copaxone (glatiramer acetate injection) filed by Mylan Inc has been accepted by the US FDA. According to a released issued by Natco Pharma Ltd., its marketing partner Mylan was one of the first companies to have filed a substantially complete ANDA containing a Paragraph IV certification for the product. "It expects to be eligible for 180 days of marketing exclusivity in the US upon final FDA approval," the Hyderabad-based company said.
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