Ranbaxy Laboratories has received approval from the US Food and Drug Administration (USFDA) to manufacture and market Fosinopril Sodium and Hydrochlorothiazide Tablets, 10 mg/ 12.5 mg and 20 mg /12.5 mg, the company said in a release issued to the BSE. The 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(R) of Bristol Myers Squibb, the release added. The total market sales for Monopril-HCT totaled $24.2 million (IMS -MAT September 2004). Monopril- HCT is indicated for the treatment of hypertension. Theses fixed dose combination are not indicated for initial therapy.
