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Ranbaxy gets US FDA nod for Lisinopril

Our Bureau

NEW DELHI, July 3

RANBAXY Pharmaceuticals Inc (RPI) has received a final approval from the US-FDA to manufacture and market Lisinopril+Hydrochlorothiazide tablets, indicated for the treatment of hypertension.

Based on bio-equivalence studies, it has been deemed to be bio-equivalent and therapeutically equivalent to Prinizide tablets by Merck Research Laboratories, a company release said here on Wednesday.

A wholly-owned subsidiary of Ranbaxy Laboratories Ltd (RLL), RPI has also received approval from the US-FDA to manufacture and market Lisinopril tablets USP, 2.5 mg, 5 mg, 10 mg, 20 mg and 40 mg also for hypertension, either alone as initial therapy or concomitantly with other classes of anti-hypertensive agents.

This product too was said to be bio-equivalent and therapeutically equivalent to Zestril tablets, an RLL note said. The significance of the approval is that all strengths of this combination product will be available along with Lisinopril as a single entity formulation.

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