How To Determine The Appropriate Listed Drug For Your 505(b)(2) Product Development Program And NDA

In accordance with 21 CFR 314.54, to obtain approval for a new product via the 505(b)(2) pathway relying upon the Agency’s findings of safety and efficacy for a previously-approved drug, the applicant must explicitly identify at least one “listed drug” for which FDA has made a finding of safety and effectiveness, containing the same active ingredient as the applicant’s new product. According to 21 CFR 314.3, a listed drug is defined as “a new drug product that has been approved under section 505(c) of the FD&C Act for safety and effectiveness or under section 505(j) of the FD&C Act, which has not been withdrawn or suspended under section 505(e)(1) through (5) or section (j)(6) of the FD&C Act, and which has not been withdrawn from sale for what FDA has determined are reasons of safety or effectiveness.” The FDA’s Orange Book, also known as the Approved Drug Products with Therapeutic Equivalence Evaluations, categorizes these products as “active” or “discontinued” depending on whether the product is approved for sale (prescription or over‑the‑counter) or has been withdrawn from market, respectively. The Orange Book is a primary resource for identifying the most appropriate listed drug candidates for your 505(b)(2) application.