Qapzola
Generic name: apaziquone
Treatment for: Bladder Cancer
Spectrum Pharmaceuticals Receives Complete Response Letter from FDA for Qapzola
On November 17, 2016, Spectrum Pharmaceuticals, Inc. (the “Company”) received a Complete Response Letter from the U.S. Food and Drug Administration (the “FDA”) with respect to the Company’s New Drug Application for Qapzola (apaziquone for intravesical instillation). On November 15, 2016, the Company met with the FDA to discuss the strategy for further development of Qapzola. Based on the discussions, the Company is evaluating a new smaller study that would replace the ongoing Phase 3 program in which enrollment has been stopped.
Posted: November 2016
Related articles
- FDA Advisory Committee Votes that Qapzola (apaziquone) Has Not Shown Substantial Evidence of a Treatment Effect Over Placebo - September 14, 2016
- Spectrum Pharmaceuticals Announces FDA's Acceptance of NDA Filing for EOquin (apaziquone for intravesical instillation) - February 19, 2016
Qapzola (apaziquone) FDA Approval History
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