USFDA nod to Zydus Lifesciences cancer drug Cyclophosphamide

Ahmedabad: Pharma major, Zydus Lifesciences Limited, has announced that the Company has received final approval from the United States Food and Drug Administration (USFDA) for Cyclophosphamide Capsules USP, 25 mg and 50 mg (USRLD: Cyclophosphamide Capsules, 25 mg and 50 mg).

Cyclophosphamide is a chemotherapy medication that slows the growth of cancer cells. It treats lymphoma, myeloma, leukemia, breast cancer and ovarian cancer.

The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ, India.

Cyclophosphamide Capsules USP, 25 mg and 50 mg had annual sales of USD 6 mn in the United States (IQVIA MAT October,2023). The group now has 383 approvals and has so far filed over 448* ANDAs since the commencement of the filing process in FY 2003-04.

Read also: Zydus, Daewoong Pharma collaborate to co-develop, commercialise Leuprolide Long-Acting Injectable in US

Medical Dialogues team had earlier reported that Zydus Lifesciences Limited had received final approval from the USFDA for Plerixafor Injection, 24 mg/1.2 mL (20 mg/mL), Single-Dose Vial (USRLD: Mozobil Injection, 24 mg/1.2 mL [20 mg/mL]).

Read also: Zydus Lifesciences bags USFDA nod for Plerixafor Injection