Mylan wins tentative approval for generic Lipitor
PITTSBURGH — The Food and Drug Administration has given tentative approval to a generic cholesterol drug made by Mylan, the drug maker said Thursday.
Mylan announced that it had received tentative approval for a generic version of Pfizer's Lipitor (atorvastatin calcium) in the 10-mg, 20-mg, 40-mg and 80-mg strengths.
A tentative approval means that the drug meets the FDA's conditions for approval, but the agency can't give final approval because of outstanding patent- and exclusivity-related issues. Ranbaxy Labs, which won approval for the first generic version of the drug in November, currently has the exclusive right to compete with Pfizer's version and will until May.
Lipitor had sales of $8.2 billion in 2011, according to IMS Health.