Glenmark gets USFDA nod for migraine drug
New Delhi: Glenmark Pharmaceuticals on Monday said it has received US health regulator's approval to market generic version of Merck's Maxalt MLT tablets, used to treat migraine headaches, in the American market.
Glenmark Generics Inc, USA, a subsidiary of the company, has received final approval from the US Food and Drug Administration (US FDA) for or Rizatriptan Benzoate orally disintegrating tablets (ODT) in strengths of 5 mg and 10 mg, Glenmark Pharma said in a statement.
"The company will commence shipping immediately," it added.
According to IMS Health, for the 12 month period ending March 2013, Rizatriptan ODT achieved sales of USD 263 million.
Glenmark's current portfolio consists of 87 products authorised for distribution in the US market and 53 abbreviated new drug applications (ANDA)'s are pending approval with the USFDA.
"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," the company added.
Shares of Glenmark were trading at Rs 575 apiece on the BSE in afternoon trade, up 1.13 per cent from their previous close.