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Acerus Receives Notice of Deficiency – Withdrawal Letter from Health Canada Regarding Gynoflor Application
Jan. 25, 2019 09:48AM PST
Pharmaceutical InvestingAcerus Pharmaceuticals (TSX:ASP) is today advising that it has received a Notice of Deficiency-Withdrawal Letter for its Gynoflor New Drug Submission. As quoted in the press release: “We are disappointed with the Health Canada decision on GynoflorTM,” said Ed Gudaitis, President and CEO of Acerus Pharmaceuticals. “GynoflorTM is currently approved in over 40 countries across Europe, Asia, …
Acerus Pharmaceuticals (TSX:ASP) is today advising that it has received a Notice of Deficiency-Withdrawal Letter for its Gynoflor New Drug Submission.
As quoted in the press release:
“We are disappointed with the Health Canada decision on GynoflorTM,” said Ed Gudaitis, President and CEO of Acerus Pharmaceuticals. “GynoflorTM is currently approved in over 40 countries across Europe, Asia, the Middle East, Africa and South America and we are understandably surprised that we could not obtain approval in Canada. We will study the details of the Notice and work with Medinova AG, the manufacturer and licensor of GynoflorTM, to assess our next steps.”
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