Glenmark gets USFDA approval for sclerosis treatment drug

Drug firm Glenmark Pharmaceuticals said that it has received US health regulator’s approval to market Riluzole tablets, used in treating nervous system disorder, in the American market.

Glenmark Generics Inc, the US-based subsidiary of Glenmark Generics Ltd (GGL) has received final approval from the US Food and Drug Administration (USFDA) for Riluzole tablets in 50 mg strength, Glenmark Pharma said in a statement.

The company will commence shipping the drug immediately to the US market, it added.

Riluzole is indicated for the treatment of amyotrophic lateral sclerosis. As per the IMS Health sales data for the 12 month period ended March 2013, Riluzole had garnered sales of $64 million in the US market.

The Mumbai-based firm said its current portfolio consists of 86 products authorised for distribution in the US market and 52 abbreviated new drug applications (ANDAs) are pending with the US FDA for approval.

“In addition to these internal filings, Glenmark Generics Inc continues to identify and explore external development partnerships to supplement and accelerate the growth of the existing pipeline and portfolio,” the company said.