Drug firm Glenmark today 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.
Shares of Glenmark were trading at Rs 346.05 on the Bombay Stock Exchange in the late afternoon trade, down 2.38 per cent from its previous close.
