Ranbaxy gets tentative USFDA nod for amlodipine

Ranbaxy Laboratories has received a tentative approval from the US Food and Drug Administration (USFDA) to manufacture and market the generic version of amlodipine besylate tablets (amlodipine), a hypertension and angina drug marketed by Pfizer as Norvasc tablets.

The approval is for tablets of 2.5, 5 and 10 mg strengths. Total annual market sales for amlodipine is $2.79 billion, according to IMS, a pharmaceutical market intelligence company, data in March 2007.

"We are pleased to receive this tentative approval for amlodipine. This product represents a future opportunity for Ranbaxy and will he launched following the final approval from FDA," Jim Meehan, vice president (sales and marketing), Ranbaxy Pharmaceuticals Inc (RPI), USA, said.

Florida-based 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.