Acerus receives Notice of Deficiency from Health Canada for Gynoflor
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Health Canada requests additional technical information on Gynoflor to complete its assessment of the product.
Acerus Pharmaceuticals Corporation has received a Notice of Deficiency (NOD) for its Gynoflor New Drug Submission.
In its notice, Health Canada requested additional technical information on Gynoflor to complete its assessment of the product, which the company believes will cause a delay in the review process.
“Such requests are not unusual during the regulatory review”, said Luc Mainville, Interim Chief Executive Officer of Acerus. “Gynoflor is approved in 41 countries across Europe, Asia-Pacific, the Middle East, Africa and South America, and it is estimated that up to 32.7 million women worldwide have been treated with the product to date. We look forward to working with Health Canada to bring this important treatment option to Canadian patients as expeditiously as possible”.
Gynoflor, a product licensed to Acerus in Canada by Medinova AG, is an ultra-low dose vaginal estrogen therapy with the addition of lactobacillus, for the treatment of atrophic vaginitis, certain vaginal infections and/or to restore a healthy vaginal environment.
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