FDA Accepts Dermadexin 510(k) Submission

Cipher Pharmaceuticals has received an Acceptance Review Notification from the U.S. Food and Drug Administration (FDA) for its 510(k) submission for Dermadexin, a patent-protected topical barrier repair cream that targets seborrheic dermatitis. Cipher acquired the worldwide rights to Dermadexin earlier this year. It was approved in the European Union in 2014 as a Class III medical device for the alleviation of symptoms of redness, scaling and itching associated with facial dermatitis.

“The acceptance of our Dermadexin submission marks Cipher’s first regulatory filing with the FDA since Absorica in 2011,” said Shawn Patrick O'Brien, president and CEO of Cipher Pharmaceuticals. “A key component of our strategy is to expand our U.S. portfolio of commercialized products and leverage our strong U.S. commercialization capability to accelerate growth. In addition to Dermadexin, we are planning a 510(k) submission to the FDA for Pruridexin in the coming weeks. Each of these products represents an excellent opportunity to target common, chronic conditions that are insufficiently addressed today.”

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