October 14, 2017
Authored and Edited by Glen Cheng, M.D.; Basil "Bill" J. Lewris
On October 13, 2017, FDA released a Draft Guidance for Industry titled “Determining Whether to Submit an ANDA or a 505(b)(2) Application.” The Guidance is intended to assist applicants in determining which one of the abbreviated approval pathways is appropriate for the submission of a marketing application to FDA.
The Guidance describes four categories of drug marketing applications:
(1) a “stand-alone NDA,” which contains full reports of investigations of safety and effectiveness that were conducted by or for the applicant or for which the applicant has a right of use;
(2) a 505(b)(2) application, which contains full reports of investigations of safety and effectiveness, where at least some of the studies were not conducted by or for the applicant and for which the applicant has not obtained a right of reference or use;
(3) an ANDA, which is an application for a duplicate of a previously approved drug product that was submitted and approved under section 505(j), and which must be bioequivalent to the reference listed drug (RLD); and
(4) a petitioned ANDA, which is a drug that differs from the RLD in its dosage form, route of administration, strength, or active ingredient (in a product with more than one active ingredient) and for which FDA has determined that studies are not necessary to establish the safety and effectiveness of the proposed drug product.
The four categories of drug marketing applications lie on a spectrum, ranging from stand-alone NDAs requiring full reports of investigations of safety and effectiveness for which the applicant has a right of use, to ANDAs that duplicate reference listed drugs and only require bioequivalence data. Within this spectrum, 505(b)(2) applications and petitioned ANDAs differ in some respects from both stand-alone NDAs and ANDAs.
The Guidance seeks to clarify certain regulatory considerations and scientific considerations to guide applicants in determining whether to submit an ANDA versus a 505(b)(2) application. This summary focuses on the three regulatory considerations highlighted in FDA’s Guidance:
(1) Duplicates. FDA generally will refuse to file a 505(b)(2) application for a drug that is a duplicate of an RLD and eligible for approval under 505(j). Thus, marketing applications for drugs that are duplicates of RLDs should be filed as ANDAs.
(2) Petitioned ANDAs. As previously noted, petitioned ANDAs can differ from RLDs in dosage form, route of administration, strength, or active ingredient (in a product with more than one active ingredient), as long as FDA determines that studies are not necessary to establish the safety and effectiveness of the proposed drug product. In order to qualify as a petitioned ANDA, an applicant should first submit a suitability petition under 21 C.F.R. 314.93. An ANDA that cites a suitability petition that has not been approved will not be received for review. FDA will approve a suitability petition unless: (1) it determines that it cannot evaluate the safety and effectiveness of the proposed change from the RLD without requiring data exceeding that typically required for an ANDA; or (2) the petition is for a drug product that has been approved in an NDA, including a 505(b)(2) application. If a 505(b)(2) application is approved for a drug product that is a pharmaceutical equivalent to the drug product described in the suitability petition, there is no need to submit a petitioned ANDA, and the applicant should instead submit an ANDA referencing the approved product as the RLD. If at the time of the approval of the 505(b)(2) NDA for the pharmaceutical equivalent of a RLD an applicant has pending a petitioned ANDA for that same pharmaceutically equivalent drug product, FDA will require the ANDA applicant to submit a new ANDA that identifies the pharmaceutically equivalent product as the RLD and that complies with applicable regulatory requirements.
(3) Bundling. An applicant may seek approval for multiple drug products containing the same active ingredients, when some of these products would qualify for approval as ANDAs and others would qualify for approval as 505(b)(2) applications. In these circumstances, FDA has permitted applicants to submit a single 505(b)(2) application for all of the bundled drug products. An example of such bundled products is where an applicant seeks approval for multiple strengths of a drug product, but only some of those strengths are listed in the Orange Book as RLDs. In such a case, FDA would permit a single 505(b)(2) application for all of the proposed strengths.
The Guidance also details several scientific considerations to account for when deciding whether to file an ANDA or a 505(b)(2) application. These scientific considerations, along with the above-discussed regulatory considerations, are discussed in the Finnegan IP Update on FDA’s Draft Guidance.
FDA’s Draft Guidance can be found here.
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