Allergan, a leading global pharmaceutical company, confirmed that it has received final approval from the U.S. 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 to customers in the U.S.
“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 & President, Generics and Global Operations.
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.
CRESTOR is a licensed trademark of AstraZeneca.