Spectrum ‘turnaround’ mode? Submits HDAC belinostat NDA
By Randy Osborne
Tuesday, December 10, 2013
Shooting for an accelerated approval with priority review, Spectrum Pharmaceuticals Inc. submitted the new drug application (NDA) for belinostat, a pan-histone deacetylase (HDAC) inhibitor for relapsed or refractory peripheral T-cell lymphoma (PTCL), and it expects a response from the FDA within 60 days.
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