Glenmark Gets Tentative FDA Nod for Sanofi's Generic Multaq

BANGALORE: Glenmark Pharmaceuticals today said it has received a tentative nod from the U.S. health regulator for generic version of Sanofi-Aventis' cardiac drug Multaq.

 In a BSE filing, Glenmark said it "has been granted tentative approval by the U.S. Food & Drug Administration (USFDA) for its Dronedarone Tablets, 400 mg, the generic version of Multaq Tablet, 400 mg of Sanofi-Aventis U.S. LLC.

" However, the company cannot sell the product in the U.S. as it is involved in a patent litigation with Sanofi in the district court of Delaware.

Sanofi and Sanofi-Aventis filed the suit against Glenmark and Dublin-based Actavis (Watson) on February 26, 2014 in the U.S. court seeking to prevent the duo from commercialising its ANDA product prior to the expiration of certain U.S. patents.

 "Glenmark believes that it is one of the first companies to have filed a substantially complete ANDA... and expects to be eligible for 180 days generic drug exclusivity upon final FDA approval," the company added.

Quoting IMS Health sales data, Glenmark said for the 12 months to November 2015, Multaq market achieve annual sales of around $425.7 million.

The company's current portfolio consists of 104 products authorised for distribution in the U.S. marketplace and 62 Abbreviated New Drug Applications (ANDA) pending approval with the USFDA. Glenmark Pharmaceuticals shares were trading at 941.10 in morning trade on BSE, up 0.89 percent.

Read More: Ratan Tata, Ronnie Screwvala Invest In Pet Care Portal Dogspot.In

Bollywood Revenues May Cross " border="0" height="11" src="file:///C:UsersadminAppDataLocalTempmsohtmlclip11clip_image001.jpg" width="10" />19,300 Cr by FY17