ARTICLE | Company News

AZ facing more generic Crestor competition

July 20, 2016 7:00 AM UTC

On Tuesday, a federal judge in the U.S. District Court for the District of Columbia denied a motion from AstraZeneca plc (LSE:AZN; NYSE:AZN) seeking a temporary restraining order to prevent FDA from approving generic versions of Crestor rosuvastatin. After the ruling, Mylan N.V. (NASDAQ:MYL) launched a generic rosuvastatin on Wednesday.

In a suit against FDA, AstraZeneca had sought to prevent the agency from approving Crestor generics until the May 2023 expiration of Orphan Drug exclusivity for the drug's recently approved indication of treating homozygous familial hypercholesterolemia (HoFH) in pediatric patients. ...