APP gets six months' marketing exclusivity for generic ifosfamideLOS ANGELES, CA. -- American Pharmaceutical Partners (APP) says it has received approval from the FDA for the Abbreviated New Drug Application (ANDA) of Ifosfamide for Injection, USP, with 180 days of marketing exclusivity with regard to generic ifosfamide.
APP expects to begin marketing individually packaged 1g vials of ifosfamide, the generic equivalent of Ifex marketed by Bristol-Myers Squibb Company, in August 2002.
Patrick Soon-Shiong, M.D., Chairman, President and CEO said: "Ifosfamide will be the 13th product and 35th dosage formulation in APP's oncology product offering. Together with the previous approval of cisplatin, approvals since January 2001 of floxuridine, mesna, pamidronate, carboplatin and ifosfamide represent a significant arsenal in the treatment of solid tumors."
Ifosfamide, used in combination with certain other approved antineoplastic agents, is indicated for third line chemotherapy of germ cell testicular cancer. It should ordinarily be used in combination with a prophylactic agent for hemorrhagic cystitis, such as mesna.
"Currently, ifosfamide is sold in prepackaged kits also containing mesna, a drug used in combination with ifosfamide and other chemotherapeutic agents. Our market research indicates that healthcare providers want the flexibility to purchase ifosfamide and mesna individually, which is why we will market these products separately. In addition, we will offer ifosfamide in a powdered form, obviating the need for refrigeration storage as is currently required for the ifosfamide/mesna kits," Soon-Shiong added.
Ifosfamide for Injection, USP will be bar coded at the individual unit-of-use level, in an attempt to increase patient safety by reducing the possibility of medical errors.
APP is one of the largest producers of injectable pharmaceuticals, with more than 100 generic products in more than 300 dosages and formulations. For more information, visit www.appdrugs.com
Posted: June 2002