Glenmark receives tentative approval Fingolimod Capsules; shares down

Pharma-major Glenmark Pharmaceuticals Inc, on Monday announced that it has been granted tentative approval by the United States Food & Drug Administration (U.S. FDA) for Fingolimod Capsules, 0.5 Mg, the generic version of Gilenya Capsules of Novartis Pharmaceuticals Corp.

According to IMS Health sales data for the 12 month period ended on January 2017, Gilenya Capsules, 0.5 mg achieved annual sales of approximately $2.03 billion. 

Glenmark’s current portfolio consists of 112 products authorized for distribution in the US marketplace and approximately 65 ANDA’s pending approval with the US FDA, the company said. 

The shares of the company plunged on the announcement. At 1128 hours the shares of the company were trading at Rs 876.20 per piece, down 1.15% or Rs 10.15 on BSE.