Published on February 2, 2010 at 11:35 PM
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that
the U.S. Food and Drug Administration (FDA) has accepted for filing
Teva’s Biologics License Application (BLA) for XM02, a granulocyte
colony-stimulating factor (G-CSF) for the reduction in the duration of
severe neutropenia and the incidence of febrile neutropenia in patients
treated with established myelosuppressive chemotherapy for cancer.
Teva's BLA for XM02 was submitted to the FDA on Nov. 30, 2009. The
proposed trade name for XM02 is NEUTROVAL™.
As previously announced, XM02 was principally developed as a similar
biological medicinal product to Neupogen®, the trademark for filgrastim
(G-CSF). In September 2008, XM02 received marketing authorization in the
European Union (EU) where a biosimilars pathway exists. XM02 was
launched in several EU markets under the trade name TevaGrastim® and
will be launched in additional EU markets over time.
SOURCE Teva Pharmaceutical Industries Ltd.,