The FDA has questioned whether CIP-Isotretinoin should be filed under a new drug application (NDA) since it considers the drug eligible for submission as an abbreviated new drug application (generic).
A generic drug product is one that is comparable to an innovator drug product in dosage form, strength, route of administration, quality, performance characteristics and intended use. In order to gain regulatory approval for a generic version of a drug it is only necessary to submit an abbreviated new drug application, which shows bio-equivalence to the already approved brand drug. It is not usually necessary to submit data from pre-clinical or clinical studies.
Cipher has the opportunity to meet with the FDA to discuss the filing, which it says it will do as soon as possible.
“We believe that CIP-Isotretinoin is sufficiently differentiated from other available isotretinoin products to qualify for filing as a 505(b(2)NDA. We intend to work closely with the agency to resolve this matter,” said Larry Andrews, president of Cipher.