The Hindu Business Line : Ranbaxy gets FDA clearance for hypertension drug

RANBAXY Laboratories has received approval from the US Food and Drug Administration (USFDA) to manufacture and market Fosinopril Sodium tablets in 10 mg, 20 mg, and 40 mg strengths used mainly for treatment of hypertension.

The Office of Generic Drugs, USFDA, has determined the Ranbaxy formulations to be bioequivalent and have the same therapeutic effect as that of the reference listed drug, Bristol Myers Squibb Company's Monopril tablets 10 mg, 20 mg, and 40 mg, respectively.

The total sales for Fosinopril Sodium tablets last year stood at $267 million.

Fosinopril is also indicated in the management of heart failure as adjunctive therapy when added to conventional therapy.

In a statement, Mr Jim Meehan, Vice-President (Sales and Marketing), Ranbaxy Pharmaceuticals Inc, 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 US healthcare system and patients."

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