Soligenix Receives Conditional FDA Acceptance of Proposed Brand Name HyBryte for SGX301 in CTCL
April 07, 2021 at 07:00 am
Soligenix, Inc. announced that the U.S. Food and Drug Administration (FDA) has conditionally accepted HyBryte™ as the proposed brand name for SGX301 (synthetic hypericin), the Company's novel first-in-class photodynamic therapy for first-line treatment of early stage cutaneous T-cell lymphoma (CTCL). The name HyBryte™ was developed in compliance with the FDA'sGuidance for Industry, Contents of a Complete Submission for the Evaluation of Proprietary Names. The FDA's conditional approval validates HyBryte™ as a proprietary name that is consistent with the FDA's goal of preventing medication errors and potential harm to the public by ensuring that only appropriate proprietary names are approved for use. Final approval of the HyBryte™ brand name is conditioned on FDA approval of the product candidate, SGX301.