Ranbaxy receives USFDA approval for Simvastatin tablets

New Delhi, Dec 21 (UNI) Ranbaxy Laboratories Ltd today said it has received approval from the United States Food and Drug Administration (USFDA) to manufacture and market Simvastatin tablets of 5 mg, 10mg, 20mg and 40mg in the US.

Simvastatin tablets are indicated in the treatment of patients with coronary heart disease (CHD) or at high risk of CHD. According to IMS-MAT, total annualised market sales for Simvastatin were 4.8 billion dollars, of which 4.2 billion dollars were for the 5mg, 10mg, 20mg and 40mg tablets.

''Ranbaxy has marketed the 80 mg tablets of Simvastatin on an exclusive basis since the patent expired in June of this year. We are now in a position to expand our product offerings to include the four additional strengths of Simvastatin and can now offer the complete line of marketed strengths for this product to our customers,'' Ranbaxy Pharmaceuticals Inc (RPI) Vice President of Sales and Marketing Jim Meehan said.

Ranbaxy Pharmaceuticals Inc, based in Florida, is a wholly-owned subsidiary of the company. RPI is engaged in the sale and distribution of generic and branded prescription products in the US healthcare system.

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