FDA gives tentative approval to Mylan's generic Crestor
SILVER SPRING, Md. — Mylan has received tentative approval for a generic version of a cholesterol drug made by AstraZeneca, according to Food and Drug Administration records.
The FDA gave the tentative approval to Mylan's rosuvastatin calcium tablets in the 5 mg, 10 mg, 20 mg and 40 mg strengths. The drug is a generic version of AstraZeneca's Crestor, which had sales of $5.1 billion in 2012, according to IMS Health.
A tentative approval means that the drug meets the FDA's conditions for approval, but the agency can't approve it yet because the patent on the branded has not yet expired. AstraZeneca's patents on Crestor are set to expire between 2016 and 2022, according to FDA records.