FDA resumes review of Daewoong Pharmaceutical’s Nabota

FDA resumes review of Daewoong Pharmaceutical’s Nabota - US FDA announcement expected next early February Daewoong Pharmaceutical’s botulinum toxin, Nabota(DWP-450)’s US launch will be determined by next February. On Aug. 30, Daewoong Pharrmaceutical (CEO Sengho Jeon) announced that it received an acceptance letter for resubmission of Biologic License Application for Nabota. As a follow up to the Complete Response Letter (CRL) received from FDA last May, Daewoong submitted additional documents on Aug. 2. According to the Prescription Drug User Fee Act (PDUFA), FDA must review the additional documents and check whether all items in CRL have been developed and notify resumption of review, class and goal date for review completion within 30 days from receipt of resubmission. According to FDA letter, the review process for approval of Nabota will take 6 under the PDUFA, and the goal date is Feb. 2, 2019. Seongsu Park, head of Nabota Business HQ, said, “As FDA accepted resubmission for approval of Nabota, we can finally visualize US market entry by next spring. We will be thorough in approval and launch processes for a successful US market penetration.” #  #  # [Photo] Daewoong Pharmaceutical’s Botulinum Toxin ‘Nabota’

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