Ranbaxy Laboratories Ltd announced that it has received approval from the US Food and Drug Administration to manufacture and market fosinopril sodium tablets in 10 mg, 20 mg, and 40 mg strengths.
The Office of Generic Drugs, US FDA, has determined the Ranbaxy formulations to be bioequivalent and have the same therapeutic effect as that of the reference listed drug monopril tablets 10 mg, 20 mg, and 40 mg, respectively. Total market sales for fosinopril sodium tablets were $267 million (IMS - MAT: December 2003).
Fosinopril sodium tablets are indicated for the treatment of hypertension and may be used alone or in combination with thiazide diuretics. Fosinopril is also indicated in the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics with or without digitalis.
Commenting on the approval, Jim Meehan, vice president, sales and marketing, Ranbaxy Pharmaceuticals Inc. (RPI) said "We will begin shipping immediately and will be able to provide this product to our distribution customers in a matter of days. Subsequently, this affordable, generic alternative will have a positive economic impact that will benefit the U.S. healthcare system, patients and prescribers".
Ranbaxy Pharmaceuticals Inc. (RPI) based in Jacksonville, Florida, is the wholly owned subsidiary of Ranbaxy Laboratories Limited (Ranbaxy), India's largest pharmaceutical company. RPI is engaged in the sale and distribution of generic and branded prescription products in the U.S. healthcare system.