FDA approves Mylan's generic version of CellCept

PITTSBURGH The Food and Drug Administration has given final approval to Mylan for its generic version of a drug used to prevent organ rejection in transplant patients.

Mylan announced Thursday the approval of its mycophenolate mofetil tablets in the 500-mg strength and capsules in the 250 mg strength and has begun shipping both.

The drug is a generic version of Roche’s CellCept, used in patients receiving kidney, heart and liver transplants. The tablets and capsules had 2009 sales of approximately $680 million and $367 million, respectively, according to IMS Health data.

Earlier this week, Roxane Laboratories reported that it received FDA approval for its generic version of CellCept.