Zydus Cadila gets US-FDA nod for Pravastatin Sodium tablets

Mumbai, June 15 (UNI) Pharma major Cadila Healthcare Ltd has received a tentative approval from the US FDA to market Pravastatin Sodium Tablets, 10 mg, 20 mg, 40 mg and 80 mg, in the US market.

Announcing this, the company said the drug, a lipid lowering agent falls in the cardiovascular segment. The branded sales of Pravastatin Sodium Tablets in the US market was estimated at USD 1.8 bn last year as per NDC. The company will market the drug through its US subsidiary Zydus Pharmaceuticals (USA) Inc, following patent expiry.

This marks the 15th ANDA (abbreviated new drug application) approval for the group since commencement of filing process in FY 2003-04. So far, the group has filed 36 ANDAs and 40 DMFs (drug master files).

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