APP Obtains FDA Approval For Idarubicin HCI Injection

APP Pharmaceuticals (APP), a wholly-owned subsidiary of Fresenius Kabi, has received approval from FDA to market idarubicin hydrochloride injection in three dosage strengths (5mg/5mL, 10mg/10mL and 20mg/20mL).

APP will package Idarubicin in 5mL, 10mL and 20mL dose vials and expects to launch it in September 2009. APP’s Idarubicin is AP-rated, bar-coded and latex-free, said the company.

Idarubicin is indicated for use as a therapy in patients with acute myeloid leukemia. Idarubicin, a cytotoxic agent, works by inhibiting activities of the cancer cell necessary for life and growth, which prevents the cancer cell from reproducing and results in death of the cancer cell.

Thomas Silberg, president and CEO of APP, said: “Idarubicin is an important addition to APP’s broad oncology portfolio. We are looking forward to launching Idarubicin within the next month and have already secured a sole source contract position with a major group purchasing organization (GPO).”