Allergan Gets FDA OK for Generic Version of AstraZeneca’s Crestor
Allergan has received final approval from the US Food and Drug Administration (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 in the US.
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 US brand sales of approximately $6.5 billion, according to IMS Health data, and as reported by Allergan.