Mezion “Fully Agreed to the US FDA’s New Drug Approval Solution for Udenafil”
Mezion responded to the company’s’Type A Meeting’ request for the US Food and Drug Administration (FDA) to submit the Udenafil New Drug Approval (NDA), “The resolution is accurate and faithful. He said on the 22nd that he showed a position that he fully agrees.
Earlier, on August 31, Mezion announced that the FDA requested for revision and supplementation of the data in accordance with the criteria for the classification form in connection with the application for the approval of the new drug for udenafil.
An official from Mezion explained, “We explained the solution to each item on how to resolve the problem and resubmit it in relation to the FDA’s official request last time.”
“We received an official reply from the US FDA on September 21,” and “FDA told us to prepare for the NDA without having to hold a separate meeting because the company explained the solution accurately and sincerely, and fully agreed (AGREE). “He added.
The company believes that the response to the FDA is an opportunity to further solidify confidence in the final approval.
An official from Mezion said, “In line with the friendly response of the US FDA, we are rapidly revising and supplementing necessary matters.” “We have already contacted about 30 hospitals and have almost completed the correction of raw data requested by the FDA I said.
In addition, he said, “We plan to make revisions to clinical data based on this,” and emphasized that “We plan to reapply for NDA with revised and supplemented data as soon as possible.”
Mezion “Fully Agreed to the US FDA's New Drug Approval Solution for Udenafil” - /10