Shilpa Medicare gets USFDA approval for IRINOTECAN injection

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

New Delhi: Shilpa Medicare recently 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.

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

Colorectal cancer that spreads to the lungs, liver or any other organ is called metastatic colorectal cancer. The most common site of metastases for colon or rectal cancer is the liver. Colorectal cancer cells may also spread to the lungs, bones, brain or spinal cord.

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

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