Epidiolex Almost Didn't Get Proprietary Name Because Of Confusion With OTC Pedia-Lax
US FDA's lead name reviewer laid out slew of reasons why the two names could be confused; her bosses agreed with the individual points, but felt that mitigation measures to avoid confusion were sufficient when considered holistically.
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FDA is worried about drug names that could appear to overstate efficacy and impact consumer and healthcare provider perceptions of the product.
After US FDA's Oncologic Drugs Advisory Committee voted to delay approval of Karyopharm's multiple myeloma drug Xpovio, the company submitted some data from the Phase III BOSTON trial, which prompted the FDA to award an accelerated approval for a narrower indication.
Chronicle of the development and review of Karyopharm's Xpovio (selinexor) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies.