Ranbaxy gets USFDA nod for Pravastatin tablets

New Delhi, Apr 25: Generic drug maker Ranbaxy Laboratories Ltd (RLL) today said it has received approval from the US Food and Drug Administration (USFDA) to manufacture and market 'Pravastatin Sodium' tablets.

RLL will manufacture the tablet, used in the treatment of cardiac diseases, in the US in dosages of 10 mg, 20 mg, 40 mg and 80 mg with an 180-day market exclusivity in the US healthcare system for the 80 mg strength.

''Pravastatin 80 mg tablets will be made available for 180 days on an exclusive basis under the Ranbaxy label,'' Ranbaxy Pharmaceuticals Inc (RPI) Vice President (Sales and Marketing) Jim Meehan said.

The 80-mg tablet alone had annual sales of 209 million dollars, while the market for all dosages of the drug was 1.19 billion dollars per year.

Pravastatin is the generic version of Bristol-Myers Squibb's cholesterol-fighter Pravachol.

RPI is engaged in the sale and distribution of generic and branded prescription products in the US healthcare system.

The product will be manufactured at Ohm Laboratories in New Brunswick, New Jersey and will be made available through wholesalers, distributors and pharmacies on a nationwide basis.

UNI