Riluzole is indicated for the treatment of amyotrophic lateral sclerosis.
United States Food and Drug Administration (USFDA) has given final approval to Glenmark Generics Inc for their abbreviated new drug application (ANDA) for Norgestimate and Ethinyl Estradiol tablets USP in the strengths of 0.18 mg/0.035 mg, 0.215 mg/0.035 mg and 0.25/0.035 mg, the company said in a statement.
Sunovion Pharmaceuticals Inc is the owner of the Eszopiclone drug.
Glenmark Generics Inc USA, the subsidiary of Glenmark Generics Ltd has received nod for it's Hydrocortisone Butyrate Cream USP (0.1 per cent), abbreviated new drug approval from the United States Food and Drug Administration, Glenmark Pharmaceuticals said in a statement.
Glenmark Generics Inc has settled the litigation pending between the company and GSK over patent actions concerning atovaquone and proguanil hydrochloride 250mg/100mg tablets, the generic version of GSK's Malarone tablets, Glenmark Pharma said.
Glenmark said it along with its US-based partner has got the US health regulator's nod to manufacture and market two oxycodone products, used for treating moderate to severe pain, in the American market. The company's US arm, Glenmark Generics Inc and Lehigh Valley Technologies (LVT) have received US Food and Drug Administration nod for Oxycodone immediate release capsules, the company said in a filing to the Bombay Stock Exchange.
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