The 505(b)(2) Experts
OYE Therapeutics is a single product, development stage company in the proprietary and advanced pharmaceuticals market seeking a niche drug label claim using the US 505(b)(2) regulatory pathway.
Our mission is to Improve lives and patient outcomes by developing new uses for old drugs using the US FDA 505(b)(2) regulatory pathway.
We focus on unmet medical needs. Over 51 million annual clinical use cases in the USA.
The 505(b)(2) new drug application (NDA) is one of three FDA drug approval pathways and represents an appealing regulatory strategy. The pathway was created by the Hatch-Waxman Amendments of 1984, with 505(b)(2) referring to a section of the Federal Food, Drug, and Cosmetic Act. The provisions of 505(b)(2) were created, in part, to help avoid unnecessary duplication of studies already performed on a previously approved (“reference” or “listed”) drug; the section gives the FDA express permission to rely on data not developed by the OYE, the NDA applicant.