USFDA grants Sun Pharma subsidiary tentative approval for generic Crestor ANDA

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Sep 30 2010

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Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE:SUNPHARMA, BSE: 524715) announced that USFDA has granted its subsidiary a tentative approval for its Abbreviated New Drug Application (ANDA) to market a generic version of IPR Pharmaceutical's Crestor ^® tablets 5 mg, 10 mg, 20 mg, 40 mg.

These generic Rosuvastatin tablets contain Rosuvastatin Calcium 5 mg, 10 mg, 20 mg, 40 mg.

Generic Rosuvastatin Calcium tablets are indicated in patients with hypertriglyceridemia as an adjunct to diet and patients with homozygous familial hypercholesterolemia.

Crestor^® has annual sales of approximately $ 3.4 billion in the US.

Source:

Sun Pharmaceutical Industries Ltd.

Posted in: Medical Condition News | Pharmaceutical News

Tags: Calcium, Cardiology, Diet, Familial Hypercholesterolemia, Gastroenterology, Hypercholesterolemia, Hypertriglyceridemia, Neurology, New Drug Application, Pharmaceuticals, Psychiatry, Rosuvastatin

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