14 March 2019 - FDA previously granted DS-200 fast track designation.
Eton Pharmaceuticals today announced that the Company has submitted a new drug application to the U.S. FDA for DS-200 via the rolling review process.
DS-200 is an injectable hospital-use product candidate. Its active ingredient is currently being supplied in the U.S market through an unapproved drug product. For a variety of historical reasons, some drugs, mostly older products, continue to be marketed in the United States in this manner. FDA guidance clearly articulates FDA’s expectation that manufacturers of products requiring FDA approval demonstrate that their products are safe and effective. If the DS-200 NDA is approved, Eton expects the current unapproved product to exit the market, consistent with FDA guidelines.