Glenmark gets USFDA nod for anti-hypertension drug

NEW DELHI: Drug firm Glenmark on Monday said it has got approval from US health regulator for its generic Felodipine tablets, an anti-hypertensive drug, in the American market.

Glenmark Generics Inc, the company's US-based arm has received final approval from the US Food and Drug Administration ( USFDA) for Felodipine extended-release tablets, Glenmark Pharmaceuticals said in a statement.

The company has got the approval for the tablets in strengths of 2.5 mg, 5 mg and 10 mg, it added.

Felodipine tablets are generic version of Astrazeneca Pharmaceuticals' Plendil. According to IMS Health, Felodipine achieved sales of $97 million in the US market for the 12 months ended September 2010.

"The company will commence marketing and distribution immediately in the US and anticipates a successful launch based on the limited competition existing in the market", it said.