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Aurobindo Pharmaceuticals gets US FDA's Tentative Approval for generic Crestor




By Vedaa MIRAZKAR - Date : 2010-05-24 - Country : INDE - Subject : Litigations - IP Field : Intellectual Property


Press Trust of India reported on May 13, 2010 that Aurobindo Pharma (an Indian pharma company listed on Bombay stock exchange) has received tentative approval of the US Food and Drug Administration (FDA) for the generic version of Crestor tablets used in the cardiovascular therapeutic area. Aurobindo has received the approval for Rosuvastatin tablets, which is generic version of US-based pharmaceutical firm IPR pharamceuticals Inc, in 5mg, 10mg, 20mg and 40 mg strength.

Aurobindo said that it has filed the abbreviated new drug application (ANDA) with FDA with Paragraph [...]

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