The company plans to market the product to treat severe, nodular acne, following approval.
Cip-Isotretinoin uses Lidose drug delivery system, which delivers more consistent bioavailability for relatively water-insoluble compounds.
The NDA is backed by pharmacokinetic studies, in which Cip-Isotretinoin demonstrated more consistent absorption under variable dietary conditions compared with existing isotretinoin products.
According to Cipher, the approval by the FDA would spur $1.0m milestone payment from its marketing partner.