Ranbaxy Laboratories Limited (RLL) has received approval from the US Food and Drug Administration to manufacture and market fosinopril Sodium and hydrochlorothiazide tablets, 10 mg/12.5 mg and 20 mg/12.5 mg, a company release said.
The Office of Generic Drugs, US Food and Drug Administration, has determined the Ranbaxy formulation to be bioequivalent and have the same therapeutic effect as that of the reference listed drug Monopril-HCT of Bristol-Myers Squibb. Total market sales for Monopril-HCT totalled $24.2 million (IMS - MAT: September 2004).
Monopril-HCT is indicated for the treatment of hypertension. These fixed dose combinations are not indicated for initial therapy.
"This final approval will allow Ranbaxy to offer the complete line of generic product formulations of Fosinopril to our customers and reflects our continued effort and commitment to supply affordable generic products to the market. Product will be made available immediately," according to Jim Meehan, vice president of sales and marketing for RPI, USA.