Cipher Provides Cip-Isotretinoin Regulatory Update
Cipher Pharmaceuticals announced that the FDA has responded to the company’s request for formal dispute resolution of the decision to issue an approvable action for Cipher’s cip-isotretinoin new drug application (NDA).
Cip-isotretinoin is an acne treatment, Cipher said.
According to the company, a representative from the FDA agreed with the Division of Dermatology and Dental Products’s view that an additional clinical study is needed to further demonstrate the safety of cip-isotretinoin.
Larry Andrews, Cipher president and CEO, said he believes that the clinical question raised was adequately addressed in the NDA, but will review the FDA’s response to determine the most appropriate path.