Karyopharm Therapeutics (KPTI) Announces Submission Of New Animal Drug Application Effectiveness And Safety Sections For Novel, Oral, Small-Molecule Selective Inhibitor Of Nuclear Export (SINE) Verdinexor For Canine Lymphoma To FDA's Center For Veterinary Medicine
1/7/2014 9:54:43 AM
NATICK, Mass., Jan. 7, 2014 (GLOBE NEWSWIRE) -- Karyopharm Therapeutics Inc., a clinical-stage pharmaceutical company focused on the discovery and development of novel first-in-class drugs directed against nuclear transport targets for the treatment of cancer and other major diseases, today announced that it has submitted to the U.S. Food and Drug Administration (FDA) Center for Veterinary Medicine (CVM), the effectiveness and safety technical sections under a New Animal Drug Application (NADA) for Verdinexor (KPT-335) for the treatment of dogs with newly diagnosed or first relapsed non-Hodgkin lymphoma (NHL). Verdinexor has received a designation from the CVM's Office of Minor Use and Minor Species (MUMS) for the treatment of companion dogs with lymphoma, and the required portions of the NADA are being submitted initially under the CVM's MUMS guidelines.
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