Strides Arcolab gets USFDA approval for generic cancer drug

NEW DELHI: Strides Arcolab today said its wholly-owned arm Onco Therapies has received approval from US health regulator for its generic version of cancer drug Ifosfamide.

The abbreviated new drug approval (ANDA) by US Food and Drug Administration is for Ifosfamide injection in multiple strengths of 50 mg/mL packaged in 1 gram/20 mL and 3 grams/60 mL single-dose vials, the company said in a statement.

Ifosfamide is part of the oncology portfolio licensed to Pfizer for the US market and the product is available for immediate launch, it added.

Citing IMS data, Strides Arcolab said the US market for generic Ifosfamide is approximately $15 million.

Ifosfamide is a chemotherapy drug that is usually used to treat sarcoma, testicular cancer and some types of lymphomas. Occasionally, it may be used to treat other types of cancer, it added.