Pharma major Ranbaxy Laboratories on said on Tuesday that it has received the final approval from US Food and Drug Administration (FDA) to make and sell hypertension drug, Amlodipine Besylate tablets in America.
The approval was given for multiple strengths of tablets in 2.5 mg (base), 5 mg (base) and 10 mg (base), Ranbaxy said in a filing to Bombay Stock Exchange.
"We are pleased to receive this final FDA approval for Amlodipine Besylate tablets, which represents Ranbaxy's 115th ANDA approval to date," Jim Meehan, Ranbaxy Pharmaceuticals Inc vice-president of sales and marketing, said.
This product will expand the company's product portfolio of affordable generic alternatives and will be launched in August this year to all classes of trade, Meehan added.
As per USFDA, Ranbaxy formulations are adjudged to be bio-equivalent having the same therapeutic effect as that of drug Norvasc tablets of Pfizer Pharmaceuticals Inc.
Total annual market sales for Norvasc, Amlodipine Besylate Tablets were 2.79 billion dollar.
Amlodipine Besylate tablets are indicated for treatment of hypertension and symptomatic chronic stable angina.
Florida-based Ranbaxy Pharmaceuticals is a wholly-owned subsidiary of Ranbaxy Laboratories. RPI sells and distributes generic and branded prescription products in the US.
Shares of Ranbaxy were trading at Rs 362.95, up 0.30 per cent on BSE.