The US Food and Drug Administration has granted approval to drug major Natco Pharma's marketing partner Mylan's Glatiramer Acetate injection used for treatment of relapsing forms of multiple sclerosis (MS).
The approval is granted to the drug in strengths of 40 mg/ml and 20 mg/ml and the product is substitutable generic version of Teva's Copaxone, Natco Pharma said in a regulatory filing today.
The launch plans for both will be communicated shortly after concurring with its partner Mylan, it added.
Natco Pharma said Copaxone is the most prescribed MS treatment for relapsing forms in the United States with brand sales for the 20 mg/ml dose at approximately USD 700 million and for the 40 mg/ml dose at nearly USD 3.64 billion for the 12 months to July 31, according to Quintiles IMS.
Close to 4,00,000 individuals in the US have MS and relapsing MS accounts for 85 per cent of initial diagnoses, it added.
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