Comments
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 UCB, Inc,” the company said in a regulatory filing.
Glenmark will market this product upon receiving final approval for 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 ended September 2015, the Vimpat market achieved annual sales of approximately $691 million.
Glenmark’s current portfolio consists of 102 products authorised for distribution in the US marketplace and 64 ANDA’s pending approval with the USFDA.
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.
Comments
Comments
Comments have to be in English, and in full sentences. They cannot be abusive or personal. Please abide by our community guidelines for posting your comments.
We have migrated to a new commenting platform. If you are already a registered user of TheHindu Businessline and logged in, you may continue to engage with our articles. If you do not have an account please register and login to post comments. Users can access their older comments by logging into their accounts on Vuukle.