Glenmark Generics receives final ANDA approval for Rizatriptan Benzoate orally disintegrating tablets

Glenmark Generics announced that the United States Food and Drug Administration (US FDA) has granted final approval for Rizatriptan Benzoate orally disintegrating tablets, its generic version of Merck’s Maxalt MLT tablets. The company will commence shipping immediately.

The approval is for the 5 mg and 10 mg of Rizatriptan ODT. According to IMS Health for the 12-month period ending March 2013, Rizatriptan ODT achieved sales of $263 million. Glenmark’s current portfolio consists of 87 products authorised for distribution in the US marketplace and 53 ANDA’s pending approval with the US FDA.

In addition to these internal filings, GGI continues to identify and explore external development partnerships to supplement and accelerate the growth of the existing pipeline and portfolio.

EP News Bureau – Mumbai