An Abbreviated New Drug Application (ANDA) for three-times-a-week generic Copaxone (glatiramer acetate injection) filed by Mylan Inc has been accepted by the US Food and Drug Administration (US FDA).
According to a released issued by Natco Pharma Ltd here on Saturday, 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 U.S. upon final FDA approval,’’ the Hyderabad-based company said.
Copaxone is indicated for the treatment of patients with relapsing forms of multiple sclerosis (MS).
In North America, it is marketed by Teva Neuroscience, Inc., which is a subsidiary of Teva and had sales of approximately $411.5 million for the 12 months ending June 30, 2014, according to IMS Health