Ranbaxy receives USFDA nod for Amlodipine Besylate tablets
Ranbaxy Laboratoris says it has received tentative US Food and Drug Administration approval to market its anti-hypertension tablets, Amlodipine Besylate, in the US.business Updated: Jun 20, 2007 22:12 IST
Country's biggest pharmaceutical firm Ranbaxy Laboratories on Wednesday said it has received tentative US Food and Drug Administration (USFDA) approval to market its anti-hypertension tablets, Amlodipine Besylate, in the US.
Ranbaxy has received the approval for the tablets in 2.5 mg, 5 mg and 10 mg strengths, the company said in a communique to the Bombay Stock Exchange.
According to IMS-MAT data for March 2007, total annual sales for Amlodipine Besylate was 2.79 billion dollars.
"We are pleased to receive this tentative approval for Amlodipine Besylate Tablets. This product represents a future opportunity for Ranbaxy and will be launched following final approval from the FDA," Ranbaxy Pharmaceuticals Inc (RPI), USA, Vice President (Sales and Marketing) Jim Meehan said.
Amlodipine Besylate tablets are indicated for the treatment of hypertension and may be used alone or in combination with other anti-hypertension agents.
The drug is also indicated for the symptomatic treatment of chronic stable angina and may be used alone or in combination with other antianginal agents.
RPI is a wholly-owned subsidiary of Ranbaxy Laboratories. RPI is engaged in the sale and distribution of generic and branded prescription products in the US.
Shares of Ranbaxy dipped 1.91 per cent and closed at Rs 351.85 on the BSE.