Cipher Reports FDA Acceptance Of 510(k) Submission For Dermadexin

(RTTNews) - Cipher Pharmaceuticals Inc. (CPHR) Tuesday said it has received an Acceptance Review Notification for its 510(k) submission for Dermadexin to the U.S. Food & Drug Administration.

The notification confirms that the submission contains all necessary elements and information needed to proceed with the substantive review.

Dermadexin is a patent-protected topical barrier-repair cream, targeting seborrheic dermatitis, an inflammatory skin disorder affecting the scalp, face, and torso, and contains the ingredient P3GCM.

Earlier this year, Cipher acquired the worldwide rights to Dermadexin and Pruridexin, two late stage products, as well as ASF-1096, a product candidate in phase II, from Astion Pharma. All three products are focused on inflammatory dermatological diseases.