Cipher gets FDA approvable letter for new acne medication; more data requested

By Elaine Rigoli

Tampa, Fla., May 2 - Cipher Pharmaceuticals, Inc. has received an approvable letter from the Food and Drug Administration pertaining to its New Drug Application for CIP-Isotretinoin, a new formulation of the acne medication isotretinoin.

In the letter, 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, according to a news release.

The company said it is 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 advisers.

"This approvable letter is encouraging and demonstrates the progress we have made on the CIP-Isotretinoin NDA since we received the Refusal to File letter last September," president Larry Andrews said in the release.

"Our intention is to work closely with the FDA to address the outstanding issues related to the NDA submission."

Mississauga, Ont.-based Cipher Pharmaceuticals is a drug development company.

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