Glenmark receives US FDA approval for two new drug

Mumbai, Jun 29 (UNI) Mumbai based Glenmark Pharmaceuticals Ltd (Glenmark), a research-based pharmaceutical company, has received final approval from the US Food and Drug Administration for its Abbreviated New Drug Applications (ANDAs) for Ondansetron Hydrochloride (HCl) Tablets.

Ondansetron HCl Tablets are the generic version of SmithKline's Zofran(R) Tablets. It is an anti-emetic drug, commonly used by cancer patients.

Glenmark is manufacturing the finished dose formulation at its USFDA approved manufacturing facility in Goa, India. Glenmark's US subsidiary, Glenmark Pharmaceuticals Inc, USA (GPI) will start marketing the product in the US.

With this approval, company now has a portfolio of 18 generic products for the US market and has over 35 ANDAs undergoing US FDA approval process.

UNI