Glenmark receives US health regulator approval for Riluzole tablets

Drug firm Glenmark Pharmaceuticals today said it had received the US health regulator's approval for marketing of Riluzole tablets, used in the treatment of nervous system disorders in the US market.

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

The company would commence shipments of the drug immediately to the US market, it said. The drug 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 notched sales of $ 64 million in the US market.

According to Mumbai-based Glenmark, its current portfolio consisted of 86 products authorised for distribution in the US market and 52 abbreviated new drug applications (ANDAs) were 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.

A subsidiary of Glenmark Pharma, GGL is focused on development, manufacture, selling and the distribution of generics through wholesalers, retailers and pharmacy chains. In afternoon today, the company's shares were trading at Rs577.85 on today, up 0.48 per cent from its previous close.