Thesaid Wednesday that it had approved generic versions of the blockbuster -lowering pill , rejecting a last-ditch and controversial effort by AstraZeneca to stop cheaper competition from reaching pharmacy shelves.
The move should considerably decrease the price of the drug and result in a sharp loss of market share for AstraZeneca. The brand-name drug has a retail price around $260 a month, according to GoodRx.com. With multiple generics now coming onto the market, the price could eventually drop as much as 80 to 90 percent.
AstraZeneca argued in a petition to the F.D.A. and in a federal lawsuit that the agency could not legally approve any generics of Crestor because the drug had recently been approved to treat children with an extremely rare disease.
It contended that the drug was in that way protected from competition, even for use in treating high cholesterol in adults, by the Orphan Drug Act, which encourages companies to develop drugs for rare diseases.