Mumbai: Drug firm Glenmark on Tuesday said its US subsidiary has received tentative approval from the US health regulator for its generic Zolmitriptan tablets used for treating migraine.
Glenmark Generics Inc, the US-based subsidiary of Glenmark Generics has received tentative approval from the US Food and Drug Administration (USFDA) for its Zolmitriptan tablets, Glenmark Pharmaceuticals said in a filing to the BSE.
The tablets are generics version of Zomig tablets from IPR Pharmaceuticals, it added.
The tentative approval is for the Zolmitriptan tablets in strengths of 2.5 mg and 5 mg, Glenmark said.
It, however, said “product launch is dependent upon receipt of final approval of its Abbreviated New Drug Application from the USFDA”.
The company said it believes that there are no first to file applicants for Zolmitriptan tablets therefore it would commence marketing and distribution of the tablets upon patent expiration in May 2013.
“IMS Health has reported sales for the 12 month period ending June 2011 as $41 million,” Glenmark said.
The company has 73 generic products authorised for distribution in the US market and has 40 ANDAs pending approval, it added.
Shares of Glenamrk Pharmaceuticals settled at Rs 324.60 on BSE, up 1.44% from previous close.