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Amendment to Levofolinic Acid NDA Accepted
"The acceptance by the FDA of the ISO-Vorin(TM) NDA amendment represents an important milestone for Spectrum as it provides validation of our risk-reduced business model," said Rajesh C. Shrotriya, M.D., Chairman, President and Chief Executive Officer of Spectrum Pharmaceuticals. "ISO-Vorin(TM) represents one of eleven promising drugs in our pipeline that have the potential to be effective therapeutic agents."
The FDA's Oncology Drug Advisory Committee had already recommended ISO-Vorin(TM) for approval, based upon clinical data demonstrating the efficacy, safety and bioequivalency in comparison to the racemic leucovorin form. During a review of the NDA application, the FDA raised questions surrounding the chemistry manufacturing and control section of the NDA. The amendment to the NDA provided manufacturing information and six months stability data on commercial batches, required by the FDA to complete its review of the ISO-Vorin(TM) NDA.
On the January 11, 2008 action date set for ISO-Vorin(TM), the FDA is expected to notify the Company whether ISO-Vorin(TM) will be approved for marketing in the US, or not.
Wyeth, Sanofi-Aventis, and others, currently market LFA in certain parts of the world, including Europe and Japan. Spectrum Pharmaceuticals maintains the rights to market LFA in the U.S., Canada and Mexico. It is estimated that the current annual market for LFA outside North America is nearly $200 million.
Source: Spectrum Pharmaceuticals