GLENMARK GETS TENTATIVE APPROVAL TO FOR GENERIC ZOFRAM

Glenmark Pharmaceuticals has received tentative approval from the FDA for its abbreviated new drug application for ondansetron hydrochloride tablets, 4, 8 and 24 mg. The drug is the generic version of GlaxoSmithKline's Zofram Tablets.

Ondansetron hydrochloride belongs to a category of antiemetics and is prescribed to help control nausea and vomiting. The drug had annual sales of approximately $640 million for the 12 months ending in June 30, according to IMS Health data.

Glenmark has also provided an update of its development pipeline. The company's asthma drug, Oglemilast, was licensed out to Forest Laboratories and Teijin Pharma for the North American and Japanese markets. This compound has recently entered Phase II trials in the U.S. The company's second lead drug, GRC 8200, a DPP-IV inhibitor for Type II diabetes, is in Phase II trials in South Africa. Glenmark's third lead compound, GRC 10389, is a CB-I receptor antagonist for the treatment of obesity. This drug is completing preclinical studies and is expected to begin Phase I trials next year.