The Hindu Business Line : Ranbaxy gets USFDA nod for cholesterol drug

Pharmaceutical major Ranbaxy Laboratories Ltd has received approval from the USFDA for manufacturing and marketing cholesterol-lowering Simvastatin tablets in the US market. The company said it has received the approval for marketing the drug in strengths of 80 mg with 180-day exclusivity.

Simvastatin, currently marketed as `Zocor' in the US, has been found to be bio equivalent by the FDA Office of Generic Drugs. The total annualised market sales for Simvastatin is $4.6 billion, of which the 80 mg strength accounts for $513 million.

"We anticipate significant benefits and value from our Simvastatin formulation to both patients and prescribers," the Ranbaxy CEO and Managing Director, Mr Malvinder Mohan Singh, said. The drug is prescribed for treatment of patients with coronary heart disease.

"We expect to launch Simvastatin 80 mg on an exclusive basis immediately. We believe that by offering an affordably priced generic alternative, we will have a positive impact on the cost of healthcare for patients who have or are at high risk for coronary heart disease," the Ranbaxy Pharmaceuticals Inc Vice-President of sales and marketing, Mr Jim Meehan, said. Mercks' patent on Zocor expired earlier this week.

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