Eugia Pharma Receives USFDA Approval for Irinotecan Hydrochloride Injection USP, 40 mg/2 mL (20 mg/mL), 100 mg/5 mL (20 mg/mL) and 300 mg/15 mL (20 mg/mL) Single-dose Vials

Eugia Pharma Limited is pleased to announce that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Irinotecan Hydrochloride Injection USP, 40 mg/2 mL (20 mg/mL), 100 mg/5 mL (20 mg/mL) and 300 mg/15 mL (20 mg/mL) Single-dose Vials.

Indications for this product include:

• Component of first-line therapy in combination with 5-fluorouracil (5-FU) and leucovorin (LV) for patients with metastatic carcinoma of the colon or rectum;
• Patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy.

Refer to package insert for full prescribing information and Boxed Warning.