Daewoong Pharmaceutical resubmits botulinum toxin product 인터넷 바카라 사이트 for approval in China with additional data

[by Yu, Suin] Daewoong Pharmaceutical announced on September 15 that it has resubmitted an application for product approval of its botulinum toxin formulation, ‘인터넷 바카라 사이트 100 Units,’ to the China National Medical Products Administration (NMPA).

The submission seeks approval for the temporary improvement of moderate to severe glabellar lines associated with corrugator or procerus muscle activity in adults between 20 and 65 years of age.

Daewoong Pharmaceutical assessed the efficacy and safety of 인터넷 바카라 사이트, a botulinum toxin type A injectable formulation, for the treatment of moderate to severe glabellar lines, using AbbVie's ‘Botox,’ the original botulinum toxin product, as the control drug.

At week 4, the protocol-specific set (PPS) analysis for glabellar wrinkle severity (maximum frown) demonstrated a response rate of 92.2% (88.8%, 94.8%) in the 인터넷 바카라 사이트 group and 86.8% (79.2%, 92.4%) in the Botox group, corresponding to a 5.3 percentage point (%p) difference in response rates between the two groups (인터넷 바카라 사이트 and Botox). No new or unexpected safety concerns were identified with respect to adverse events.

"We initially submitted the application for approval of the 인터넷 바카라 사이트 100 Units product to the NMPA on December 30, 2021, but the local regulatory review extended beyond the standard timeframe. Accordingly, we made the decision to 'voluntarily withdraw' the application on July 30, following a comprehensive internal assessment and adjustments to our business development strategy," Daewoong Pharmaceutical stated. “We have since reapplied after thoroughly supplementing the approval documents. Our plan is to launch the product in the relevant market once approval is granted.”