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FDA to resume biologic licensing procedure for Nabota
  • By Lee Han-soo
  • Published 2018.08.30 11:26
  • Updated 2018.08.30 11:26
  • comments 0

Daewoong Pharmaceutical said Thursday that the U.S. Food and Drug Administration (FDA) has accepted the company’s biologic license application resubmission for Nabota, the company’s botulinum toxin (BTX).

The approval comes after the company handed over supplementary data with the FDA as a follow-up to the agency’s Complete Response Letter on Aug. 2.

Under the Prescription Drug User Fee Act (PDUFA), the FDA will review whether the complete response letters have been adequately addressed and let the company know if it plans to resume the biologic license application procedure, class and goal date of the reinstatement within 30 days.

According to an official letter from the FDA in line with PDUFA, the review process for Nabota will take a six-month evaluation period, and the target date for the completion will be on Feb. 2 next year.

“As the FDA accepted the company’s application resubmission for Nabota's, the company expects to enter the U.S. market by spring of next year,” said Park Sung-soo, head of Daewoong’s Nabota business division. “We will thoroughly prepare for the product’s approval and release, and successfully launch Nabota in the U.S. market.”

corea022@docdocdoc.co.kr

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