Glenmark gets tentative USFDA nod for Lacosamide tablets
Mumbai-based drug maker Glenmark Pharmaceuticals Ltd. on Friday announced that it has received tentative approvals from the United States Food & Drug Administration (USFDA) to market its Lacosamide tablets, 50 mg, 100 mg, 150 mg and 200 mg. The generic version of this medicine is currently listed under Vimpat tablets, 50 mg, 100 mg, 150 mg and 200 mg of UCB— a multinational biopharmaceutical company headquartered in Brussels, Belgium. “Glenmark will market this product upon receiving final approval of its Lacosamide Tablets, 50 mg, 100 mg, 150 mg and 200 mg ANDA. The patent listed in the Orange Book for Vimpat Tablets, 50 mg, 100 mg, 150 mg and 200 mg is scheduled to expire on March 17, 2022,” Glenmark said in an official release. “According to IMS Health sales data for the 12 month period ending September 2015, the Vimpat® market achieved annual sales of approximately $691.0 million,” the company said. The Indian drug maker currently has 14 manufacturing facilities and six R&D centers in four countries. Besides India, Glenmark sells its products in more than 80 countries including the US, the EU and South American regions. Glenmark is a leading player in the discovery of new chemical and biological molecules and now has seven molecules at various stages of clinical and pre-clinical development. These molecules are majorly focused in the areas of inflammation (asthma/COPD, rheumatoid arthritis) and pain (neuropathic pain and inflammatory pain). In the US, it operates under the name of Glenmark Generics Ltd. The company presently has 102 products authorised for distribution in the US market, while 64 ANDA (Abbreviated New Drug Application) are pending with the USFDA.
October 30, 2015 | 4:27pm IST.
to success.