Ranbaxy gets FDA nod for generic drug
Tuesday, 27 April 2004, 07:00 Hrs
NEW DELHI: India's pharma major Ranbaxy Laboratories Ltd has received the US Food and Drug Administration (FDA) approval to manufacture and market generic Fosinopril Sodium tablets recommended for hypertension. "The Office of Generic Drugs, US Food and Drug Administration, has determined the Ranbaxy formulations to be bio-equivalent and have the same therapeutic effect as that of the reference listed drug Monopril tablets of 10 mg, 20 mg, and 40 mg strength respectively," the company said a in statement Tuesday. The total market sales for Fosinopril Sodium tablets are estimated to have been $267 million in 2003. Fosinopril Sodium tablets are indicated for the treatment of hypertension and may be used alone or in combination with thiazide diuretics. It is also indicated in the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics with or without digitalis. "We will begin shipping (the tablets) immediately and will be able to provide this product to our distribution customers in a matter of days," said Jim Meehan, vice president of sales and marketing of Ranbaxy Pharmaceuticals Inc. (RPI). Based in Florida, RPI is the wholly owned subsidiary of Ranbaxy, engaged in the sale and distribution of generic and branded prescription products in the US healthcare system.