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Approval of the 48hr Nurtec ODT for migraine imminent in KOR

By Lee, Hye-Kyung | translator Alice Kang

24.12.31 05:45:49

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MFDS completes safety and efficacy review¡¦was approved by the FDA in 2020



¡®Nurtec (Rimegepant),¡¯ which is used for both the treatment and prevention of migraine, will soon receive marketing authorization in Korea.

According to industry sources on the 31st, the Ministry of Food and Drug Safety completed the safety and efficacy review of Pfizer's Nurtec Oral Disintegrating Tablet 75 mg.

Pfizer submitted a marketing authorization application for Nurtec last year, and upon the completion of the safety and efficacy review, the drug is expected to be approved soon in Korea.

Nurtec is the only oral calcitonin gene-related peptide (CGRP) receptor antagonist approved for the prevention and treatment of acute migraine in adults in the U.S. in 2021, and

Lee, Hye-Kyung(hgrace7@dailypharm.com)
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