APP Pharmaceuticals Gemcitabine HCI for Injection receives FDA approval

APP Pharmaceuticals develops, manufactures and markets injectable pharmaceutical products with a primary focus on the oncology, anti-infective, anesthetic/analgesic and critical care markets.

Gemcitabine HCI for Injection is indicated in combination with Carboplatin for the treatment of patients with advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy.

Gemcitabine HCI for Injection in combination with Cisplatin is used in patients with inoperable, locally advanced (stage IIIA or IIIB), or metastatic (stage IV) non-small cell lung cancer and in combination with Paclitaxel for metastatic breast cancer as a first-line treatment drug.

It is also indicated as first-line treatment for patients with locally advanced (nonresectable stage II or stage III) or metastatic (stage IV)adenocarcinoma of the pancreas and in patients previously treated with 5-FU.

Teva Pharmaceuticals USA has received approval and APP Pharmaceuticals launched Gemcitabine HCI for Injection in the 200 mg and 1g dosage forms as part of a commercialization, manufacture and supply agreement with Teva in January 2011.

APP Pharmaceuticals president and CEO John Ducker said with the approval of the 2 g dosage, it can manufacture all three dosage strengths of this critically important oncology drug to its customers.

Fresenius Kabi Pharmaceuticals Holding, a subsidiary of Fresenius Kabi AG, has acquired APP Pharmaceuticals in 2008.