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

Glenmark's GBR 1302 antibody enter Clinical Trials

Another breakthrough development from Glenmark Pharmaceuticals that the company has completed pre-clinical evaluation for its novel bi-specific antibody GBR 1302 and filed the Phase I trial application with German regulatory authorities.

Glenmark Pharmaceuticals SA, has submitted a clinical trial application for GBR 1302 to the Paul-Ehrlich Institute in Germany. GBR 1302 has the potential to be used in the treatment of a broad array of cancers, including breast cancer, and the company expects to obtain approval for the initiation of clinical studies during this financial year.

GBR 1302 material for Phase I clinical trials with manufactured at the Glenmark GMP production unit in Switzerland. A bi-specific monocloncal antibody is an artificial protein that is composed of fragments of two different monocloncal antibodies and consequently binds two different types of antigens.