Glenmark gets tentative FDA approval for generic version of Multaq

Glenmark Pharmaceuticals said it has received a tentative nod from US Food and Drug Administration for generic version of Cardiac drug Multaq. Dronedarone Tablets available in the strength of 400 mg tablets which is equivalent of Sanifo-Aventis Multaq Tablet 400 mg.

The company cannot sell the product in the United States 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 Actavis on 26th February, 2014 in US court seeking to prevent the duo from commercializing its Abbreviated New Drug Application product prior to the expiration of certain US patents.

The company's current portfolio consists of 104 products authorized for distribution in the US marketplace and 62 Abbreviated New Drug Applications pending approval with the USFDA.

Glenmark Pharmaceuticals

Jubilant Life Sciences receives ANDA approval for Paroxetine Tablets

Jubilant Life Sciences Ltd, an integrated global Pharmaceuticals and Life Sciences Company, has received Abbreviated New Drug Application (ANDA) final approval from the US Food and Drug Administration (US FDA) for Paroxetine Tablets USP, 10 mg, 20 mg, 30 mg and 40 mg, the generic version of Paxil Tablets, 10 mg, 20 mg, 30 mg, and 40 mg® (of Apotex), which is used as an antidepressant.

As on September 30, 2015, Jubilant Life Sciences had a total of 820 filings for formulations of which 391 have been approved in various regions globally. This includes 71 ANDAs filed in the US, of which 39 have been approved and 46 Dossier filings in Europe.

Mylan Launches Generic Zyvox Tablets

Mylan N.V. announced the U.S. launch of Linezolid Tablets, 600 mg, which is the generic version of Pfizer's Zyvox^® Tablets. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is indicated in adults and children for the treatment of certain infections caused by susceptible Gram-positive bacteria.

Linezolid Tablets, 600 mg, had U.S. sales of approximately $457.8 million for the 12 months ending Sept. 30, 2015, according to IMS Health. 

Currently, Mylan has 269 ANDAs pending FDA approval representing $100.8 billion in annual brand sales, according to IMS Health. Fifty of these pending ANDAs are potential first-to-file opportunities, representing $35.6 billion in annual brand sales, for the 12 months ending June 30, 2015, according to IMS Health.