Shilpa Medicare gets USFDA nod for Irinotecan injection to treat cancer

Irinotecan injection is used in the treatment of patients with metastatic carcinoma of the colon or rectum, the company added.

NEW DELHI: Shilpa MedicareTuesday said it has received approval from the US health regulator for Irinotecan HCL injection, used for the treatment of certain kind of cancers.

The company has received US Food and Drug Administration (USFDA) approval for its ANDA Irinotecan HCL injection USP in the strengths 40 mg/2mL and 100 mg/5mL (20mg/mL) single-dose vials, Shilpa Medicare said in a BSE filing.

Also Read: Shilpa Medicare gets tentative USFDA nod for Dimethyl Fumarate delayed release capsules

Irinotecan injection is used in the treatment of patients with metastatic carcinoma of the colon or rectum, the company added.

Quoting IQVIA MAT second quarter 2018 data, Shilpa Medicare said the US market for Irinotecan HCL is approximately USD 18 million.

Also Read: Shilpa Medicare gets USFDA nod for Gemcitabine to treat types of cancer