FDA approves Crestor's generic rivals, much to Astrazeneca's dismay

The Food and Drug Administration on Wednesday approved several generic versions of the popular cholesterol-lowering drug Crestor, after AstraZeneca fought tooth and nail to prevent the generic rivals from hitting the market, according to The New York Times.

AstraZeneca filed a petition and launched a federal lawsuit against the FDA, arguing the agency could not legally approve any generic versions of the drug due to the Orphan Drug Act, which offers seven-year market exclusivity to companies that develop treatments for rare diseases.

Since Crestor was recently approved to treat a rare disease in children, AstraZeneca claimed the drug should be protected from competition, even when used for a different purpose.

AstraZeneca's request for a temporary restraining order to prevent the FDA from approving the generics was denied by a federal judge on Tuesday. On Wednesday, the agency approved generic versions of Crestor from eight drug companies.

The approvals are expected to drastically decrease the price of the drug by 80 to 90 percent — Crestor costs $260 a month — and eliminate London-based AstraZeneca's market domination.

More articles on the drug market:

Compounded drug sales skyrocket, raise concerns over fraud
Healthcare Supply Chain Association: Generic drug competition drives down costs
FDA approves Belviq XR weight loss tablets

 

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