Zydus gets USFDA nod

New Delhi: Zydus Lifesciences Ltd on Thursday said it has received final approval from the US health regulatory for its generic version of cancer treatment drug Cyclophosphamide capsules. The approval by the US Food and Drug Administration (USFDA) is for Cyclophosphamide capsules of strengths 25 mg and 50 mg, Zydus Lifesciences said in a regulatory filing.

The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ, India, it added. Cyclophosphamide is a chemotherapy medication that slows the growth of cancer cells. It treats lymphoma, myeloma, leukemia, breast cancer and ovarian cancer, the company said.

Cyclophosphamide Capsules 25 mg and 50 mg had annual sales of USD 6 million in the US, Zydus Lifesciences said citing IQVIA MAT (moving annual total) October, 2023 data.