In it approvable letter regarding the new drug application for the drug, the FDA requested that the company, prior to receiving approval, provide additional clinical data and some further details relating to chemistry, manufacturing and controls for the product.
Cipher says that it is currently assessing these requests, including what additional clinical data may be required and is planning the most appropriate next steps in consultation with its clinical and regulatory advisors.
The approvable letter represents an improvement on the refusal to file letter that the company received in relation to its cip-isotretinoin new drug application (NDA) last September.
“Our intention is to work closely with the FDA to address the outstanding issues related to the NDA submission,” said Larry Andrews, president of Cipher.