Glenmark Pharmaceuticals receives a tentative USFDA approval for migraine tablets
The drug manufacturer has secured a tentative approval from USFDA for its generic Rizatriptan Benzoate tablets.
New Delhi, September 20, 2012: Glenmark Pharmaceuticals today said that the company has received a tentative approval from the US health regulator, US Food and Drug Administration (USFDA) for its generic Rizatriptan Benzoate tablets (used for treating migraine attacks).
It may be noted here that the company’s US arm Glenmark Generics Inc USA has received this approval and these tablets are the generic version of drug major Merck’s Maxalt tablets.
As per the IMS health data, Rizatriptan Benzoate immediate release tablets achieved sales of US$ 315 million for the 12 month period ended June 2012.
As per the current portfolio of Glenmark Pharmaceuticals, it has 81 products authorised for distribution in the US market and 41 abbreviated new drug applications (ANDAs) pending approval with the USFDA.