FDA Immediately Approves 8 Generic Versions of AstraZeneca’s Crestor
The FDA has approved 8 generic versions of the cholesterol-lowering drug Crestor (rosuvastatin calcium), despite AstraZeneca’s multiple attempts to prevent the cheaper competitor drugs from being authorized.
Earlier this week, a federal judge denied AstraZeneca’s request for a temporary order barring the FDA from approving generic copies of its drug. One day later, the FDA approved eight generic versions of rosuvastatin that had been submitted to the agency for approval.
Crestor is the second-most prescribed drug after Synthroid (levothyroxine sodium; AbbVie Inc), a thyroid medicine. Last year, Crestor was prescribed 20.3 million times.
_________________________________________________________________________________________________________________________________________________________________________
RELATED CONTENT
ASTRAZENECA SUES FDA TO PREVENT GENERIC COMPETITION FOR CRESTOR
FIRST GENERIC OF CRESTOR APPROVED BY THE FDA
________________________________________________________________________________________
According to GoodRx.com, Crestor’s retail price is about $260 per month. With multiple generic copies of the drug now coming to the market, the price of Crestor could drop by as much as 90%. Although one generic version of rosuvastatin, produced by Allergan, is already on the market, prices typically do not plummet until there are multiple generics. The newly approved generics are made by Apotex, Aurobindo Pharma, Glenmark Pharmaceuticals, Mylan, Par Pharmaceutical, Sandoz, Sun Pharmaceutical, and Teva.
After an ongoing legal battle, AstraZeneca stated in a petition and federal lawsuit addressed to the FDA that the agency could not legally approve generic version of Crestor because it was recently approved to treat children with the extremely rare condition, homozygous familial hypercholesterolemia (HoFH), granting the company 7 years of protection from generics to treat HoFH under the Orphan Drug Act. However, AstraZeneca was criticized for their tactic as an attempted abuse of the Orphan Drug Act.
Although AstraZeneca could continue its lawsuit and attempt to seek a reversal decision by the FDA, producers of the generics are expected to immediately place their products on the market.
-Julie Gould
Reference:
