The oncology drug by Hospira, a gemcitabine injection, has received approval from the US Food and Drug Administration (FDA), and the company expects to market the drug by September.
Approval has been obtained for three solution formulations of the drug, including 200 mg, 1 gm, and 2 gm with a concentration of 38 mg/ml strength.
The existing FDA approval has been sought after the Hospira’s introduction of gemcitabine HCL for injection in Nov 2010, a lyophilized or freeze-dried formulation.
The company is thrilled to offer gemcitabine in solution form to US pharmacists as its preparation is less time-consuming, stated President of Hospira Thomas Moore.
He added: “Hospira’s generic gemcitabine solution gives the medical community access to a lower-cost, more convenient offering of this key oncology drug.”