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Allergan secures FDA approval and launches generic Crestor (rosuvastatin).

Read time: 1 mins
Last updated:2nd May 2016
Published:2nd May 2016
Source: Pharmawand

Allergan plc a leading global pharmaceutical company, confirmed that it has received final approval from the FDA on its Abbreviated New Drug Application (ANDA) for rosuvastatin calcium 5, 10, 20 and 40 mg tablets, the generic version of AstraZeneca's Crestor (rosuvastatin) tablets. Following receipt of the FDA approval, Allergan is the first company to launch a generic version of Crestor to customers in the U.S.

Under the terms of the agreement reached with AstraZeneca on March 25, 2013 , Allergan has launched its generic version of Crestor 67 days prior to July 8, 2016 , the expiration of pediatric exclusivity. For the 12 months ended March 31, 2016 Crestor had total U.S. brand sales of approximately $6.5 billion , according to IMS Health data.

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