FDA has issued Final Guidance related to drug marketing application submissions for human drugs and recommendations for considerations of whether to submit a 501(b)(2) New Drug Application, commonly referred to as an NDA, or a 505(j) Abbreviated New Drug Application, commonly referred to as an ANDA. These are two of the four available pathways for drug submissions for FDA approval, with ANDA known as an abbreviated pathway.
While an NDA is required for all new drug products, administration routes, etc, an ANDA may be an appropriate submission for products which duplicate a previously reference listed drug (RLD) that FDA has already determined is safe and effective. In such cases where the active ingredient(s), dosage form, route of administration, strength, previously approved conditions of use, and labeling (with certain exceptions) mimic that of a RLD, an ANDA may be appropriate. ANDAs must still include full investigative reports of safety and effectiveness, and may also rely on FDA’s previous finding of such to the extent that the proposed drug shares the same characteristics as the RLD.
It is important to note that in cases where an ANDA is the appropriate submission choice, FDA will reject a 501(b)(2) application as a duplicate of an RLD. Therefore, a thorough consideration of the drug under submission compared to RLDs already approved by FDA is warranted. Firms wishing to outsource this review and seek recommendations on the appropriate FDA filing are invited to contact Bryan Coleman, Senior Director of Drugs and Medical Devices.