Drug news
Complete Response for EM 100 an OTC eyedrop to treat ocular itching
Eton Pharmaceuticals, Inc announced that the FDA provided Eton’s partner, Bausch Health Companies, with a Complete Response Letter relating to the application for EM 100. No concerns were raised about the clinical data in the application, so it is not anticipated that any additional clinical work will be required. A response to this letter is expected shortly, and the Company remains confident in the approvability of the product.