Zydus Cadila gets FDA approval for Revlimid generic Lenalidomide Capsules

Zydus Cadila said that the US Food and Drug Administration (FDA) has granted it tentative approval for Lenalidomide Capsules, a generic version of Celgene Corporation’s Revlimid (Lenalidomide).

The FDA tentative approval is for Lenalidomide Capsules in the strengths of 2.5 mg, 5 mg,10 mg, 15 mg, 20 mg, and 25 mg.

Lenalidomide is used for the treatment of multiple forms of cancers. It is said to work by decelerating or preventing the growth of cancer cells.

The drug is also used for the treatment of anemia in patients suffering from certain blood/bone marrow disorders (myelodysplastic syndromes-MDS).

Zydus Cadila will manufacture Lenalidomide Capsules at its formulation manufacturing plant at the SEZ, Ahmedabad.

The Indian pharma company said that it now has 320 approvals and has filed more than 400 abbreviated new drug applications (ANDAs) to date since the start of the filing process in FY 2003-04.