Glenmark Pharmaceuticals has received final approval from US Food and Drug Administration for its abbreviated new drug applications (ANDAs) for Ondansetron Hydrochloride tablets 4 mg, 8 mg and 24 mg and Ondansetron orally disintegrating tablets 4 mg and 8 mg.According to an official release issued by the company to the BSE today, the tablets are the generic version of GlaxoSmithKline's Zofran(R) tablets. It is a popular anti-emetic, commonly used by cancer patients. Wockhardt had also launched Ondansetron injection in US in December 2006.The company is manufacturing the finished dose formulation at its USFDA approved manufacturing facility in Goa.The company's US subsidiary, Glenmark Pharmaceuticals, USA (GPI) will start marketing the product in the US.With this approval, GPI now has a portfolio of 18 generic products for the US market and has over 35 ANDAs undergoing USFDA approval process.
