Glenmark drug gets tentative USFDA nod
The Indian firm's US arm wins approval to market its Ondansetron Hydrochloride tablets in America.india Updated: Sep 19, 2006 15:56 IST
Glenmark Pharmaceuticals Ltd on Tuesday said its wholly-owned US subsidiary, Glenmark Pharmaceuticals Inc, has received a tentative USFDA approval to market its Abbreviated New Drug Application (ANDA), Ondansetron Hydrochloride Tablets, in the American market.
The tentative approval is for Ondansetron Hydrochloride tablets in 4 mg (base), 8 mg (base) and 24 mg (base) dosages, the company informed the Bombay Stock Exchange.
Ondansetron Hydrochloride tablets are the generic version of GlaxoSmithKline's Zofram Tablets, which are prescribed to help control nausea and vomiting, the statement said.
The drug had annual sales of about $640 million for the year ended June 30, it added.