Daewoong Pharmaceutical’s botulinum toxin, ‘Nabota’, is expected to enter the US market in February of next year. Daewoong Pharmaceutical made an announcement on August 30th that it received an Acceptance letter from the U.S. Food and Drug Administration (FDA) that it has received a resubmission of the Biologic License Application for its botulinum toxin ‘Nabota’.
Daewoong Pharmaceutical filed a supplementary data with the FDA on August 2nd as a follow-up to the Complete Response Letter (CRL) received from the FDA last May. According to the Prescription Drug User Fee Act (PDUFA), the FDA will review whether the CRLs have been adequately addressed, and will review within 30 days of receipt the acceptance of reinstatement, class and goal date of completion of the examination.
According to the official letter from the FDA, the item permit renewal request for ‘Nabota’ will take six months to review according to the PDUFA, and the target date for the completion will be February 2, 2019.
“As the FDA accepts Nabota’s application for resubmission, entry in the U.S. market, which aims to happen on spring of next year, has entered a visible region. We will thoroughly prepare the process for the final product approval and release and launch it successfully in the U.S. market,” said Park Sung-soo, Daewoong Pharmaceutical’s Nabota Business Division Manager.