"Glenmark Pharmaceuticals Inc, USA, has been granted tentative approval by the United States Food and Drug Administration (USFDA) for Milnacipran Hydrochloride tablets, 12.5 mg, 25 mg, 50 mg and 100 mg," it said in a BSE filing.
Milnacipran Hydrochloride tablets are generic version of Savella drug, 12.5 mg, 25 mg, 50 mg and 100 mg of Allergan Sales LLC.
Citing IMS Health data for the 12 months to February 2017, Glenmark said the Savella tablets achieved annual sales of approximately USD 154.4 million.
The company's current portfolio consists of 113 products authorised for distribution in the US marketplace and 65 ANDA pending approval with the USFDA.