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Glenmark gets tentative USFDA nod for Lacosamide tablets
Glenmark Pharmaceuticals today said it has received tentative approval from the US health regulator for its Lacosamide tablets."Glenmark Pharmaceuticals Inc USA has been granted tentative approval by the United States Food and Drug Administration (USFDA) for its Lacosamide Tablets, 50 mg, 100 mg, 150 mg and 200 mg, the generic version of Vimpat Tablets, 50 mg, 100 mg, 150 mg and 200 mg of...
"Glenmark Pharmaceuticals Inc USA has been granted tentative approval by the United States Food and Drug Administration (USFDA) for its Lacosamide Tablets, 50 mg, 100 mg, 150 mg and 200 mg, the generic version of Vimpat Tablets, 50 mg, 100 mg, 150 mg and 200 mg of UCB, Inc," the company said in a regulatory filing.
Glenmark will market this product upon receiving final approval of its Lacosamide Tablets, 50 mg, 100 mg, 150 mg and 200 mg ANDA, it added.
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, the filing said.
According to IMS Health sales data for the 12-month period ending September 2015, the Vimpat market achieved annual sales of approximately USD 691 million.
In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio, it said.
Meghna A Singhania is the founder and Editor-in-Chief at Medical Dialogues. An Economics graduate from Delhi University and a post graduate from London School of Economics and Political Science, her key research interest lies in health economics, and policy making in health and medical sector in the country.She is a member of the Association of Healthcare Journalists. She can be contacted at editorial@medicaldialogues.in. Contact no. 011-43720751