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Corporate - Regulatory Bodies & Rulings
Glenmark gets US nod for nausea drug

Our Bureau

Mumbai, Sept. 19

Glenmark Pharmaceuticals Ltd has received tentative approval from the US regulatory authority for its version of Ondansetron Hydrochloride Tablets, prescribed to control nausea and vomiting.

In an announcement to the Bombay Stock Exchange, the company said that its wholly owned subsidiary in the US, Glenmark Pharmaceuticals Inc, has received tentative approval from the US Food and Drug Administration for its Abbreviated New Drug Application of Ondansetron Hydrochloride Tablets in different strengths: 4 mg (base), 8 mg (base) and 24 mg (base). Ondansetron Hydrochloride is the generic version of GlaxoSmithKline's Zofram tablets and the drug had an annual sales of about $640 million, the company said.

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