Glenmark Pharmaceuticals USA has got tentative approval from the United States Food and Drug Administration (USFDA) for Fingolimod capsules.
These capsules are used in the treatment of adult patients with relapsing forms of multiple sclerosis.
“Glenmark Pharmaceuticals USA has been granted tentative approval by the USFDA for Fingolimod capsules, 0.5 mg, the generic version of Gilenya capsules of Novartis Pharmaceuticals Corp,” Glenmark said in a BSE filing.
As per IMS Health sales data for the 12-month period ended January 2017, Gilenya capsules 0.5 mg had annual sales of approximately $2.03 billion, it added.
Shares of Glenmark Pharmaceuticals were trading 0.78 per cent down at Rs 879.45 apiece on the BSE.