Cipher CIP-isotretinoin regulatory path
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Cipher plans to meet with FDA to determine whether its CIP-isotretinoin acne product should be filed as a 505(b)(2) NDA or as an abbreviated application, the firm says Sept. 6. FDA is questioning the validity of the 505(b)(2) pathway "since they consider [the formulation] eligible for submission as an abbreviated new drug application," Cipher states. The company submitted the NDA, which it maintains should be a 505(b)(2) application, in the second quarter but FDA deemed the filing unacceptable in its current form. Cipher is pointing to food effect advantages with its isotretinoin formulation compared to Roche's Accutane brand and the three other branded generic versions of the retinoid to argue for regulation as a new product, not a generic...