Allergan receives FDA approval of Crestor
First company to launch a generic version of Crestor to customers in the US.
Allergan 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 US.
"This first-to-market launch demonstrates the talent of our Generics team in developing, manufacturing and bringing to market high-quality, affordable versions of widely used medications like Crestor. This is expected to be the largest generic launch in 2016, benefiting patients and reducing cost for U.S. health systems," said Robert Stewart, Allergan's Executive Vice President and President, Generics and Global Operations.
Under the terms of the agreement reached with AstraZeneca on 25 March 2013, Allergan has launched its generic version of Crestor 67 days prior to 8 July 2016, the expiration of pediatric exclusivity.
For the 12 months ended 31 March 2016, Crestor had total US brand sales of approximately $6.5 billion, according to IMS Health data.
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