Cipher Submits NDA Amendment for Acne Treatment

Cipher's NDA amendment provides additional clinical information requested by the FDA in support of obtaining approval for the acne medication.

Canadian drug development company Cipher Pharmaceuticals Inc. has submitted an amendment to its pending New Drug Application (NDA) to the FDA for CIP-ISOTRETINOIN, its novel, patented formulation of the acne medication isotretinoin.

Cipher is seeking approval to market CIP-ISOTRETINOIN for the treatment of severe, nodular acne. Cipher's NDA amendment provides additional clinical information requested by the FDA in support of obtaining approval.

Subject to FDA acceptance as a complete response to its outstanding comments, Cipher expects the review under the Prescription Drug User Fee Act (PDUFA) to be completed in six months.