25 January 2019 - Acerus Pharmaceuticals is today advising that it has received a Notice of Deficiency-Withdrawal Letter for its Gynoflor new drug submission. 

The Company has 30 days to decide if it wishes to file a letter of intent to file a request for reconsideration of the Notice.

“We are disappointed with the Health Canada decision on Gynoflor,” said Ed Gudaitis, President and CEO of Acerus Pharmaceuticals. “Gynoflor 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 Gynoflor, to assess our next steps.”

Read Acerus Pharmaceuticals press release