Shilpa Medicare receives USFDA approval for Irinotecan HCL Injection

Shilpa Medicare has received U.S. Food and Drug Administration (USFDA) approval for its ANDA Irinotecan HCL Injection USP, 40 mg/2mL and 100 mg/5mL (20mg/mL) Single Dose Vials.

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

According to IQVIA MAT Q2 2018 data, the US market for Irinotecan HCL approximately USD 18 million.

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