NEW DELHI: Shilpa Medicare Tuesday said it has received approval from the US health regulator for Irinotecan HCL injection, used for 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.
Quoting IQVIA MAT second quarter 2018 data, Shilpa Medicare said the US market for Irinotecan HCL is approximately USD 18 million.
Shares of Shilpa Medicare were trading 3.80 per cent up at Rs 398.65 apiece on BSE.