Find what matters to you

While a 505(b)(2) NDA can potentially get a drug to market faster than a 505(b)(1) NDA, the choice of a bridging strategy to the listed drug is important and involves consideration of multiple factors.

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.

The advantages afforded the 505(b)(2) applicant are significant in that the applicant is able to reference safety and efficacy data in the marketing application of the innovator product rather than conduct costly preclinical and clinical studies. Find out if your product qualifies.