Sun Pharma receives tentative USFDA approval for generic Crestor
30 Sep 2010
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Mumbai-based Sun Pharmaceutical Industries Ltd has announced that the US FDA has granted its US subsidiary a tentative approval for its abbreviated new drug application (ANDA) to market a generic version of IPR Pharmaceutical's Crestor tablets in dosage forms of 5mg, 10mg, 20mg and 40mg.
These generic rosuvastatin tablets contain rosuvastatin calcium in 5mg, 10mg, 20mg and 40mg dosages.
Generic rosuvastatin calcium tablets are indicated in patients with hypertriglyceridemia as an adjunct to diet and patients with homozygous familial hypercholesterolemia.
Crestor has annual sale of approximately $ 3.4 billion in the US.
Crestor is licensed from Japan's Shionogi & Co, Ltd. Crestor is a registered trademark of the AstraZeneca group of companies.
