Eton Pharmaceuticals announced the U.S Food and Drug Administration (FDA) provided Eton’s partner with a Complete Response Letter (CRL) relating to the application for EM-100, an over-the-counter (OTC) preservative-free formulation eye drop for the treatment of ocular itching associated with allergic conjunctivitis. The FDA's CRL means the agency will not approve the application or abbreviated application in its present form.

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.

 "We believe the issues cited in the CRL can be addressed in the coming months, and we remain confident that EM-100 will be available to patients as quickly as possible," said Sean Brynjelsen, Chief Executive Officer of Eton Pharmaceuticals.

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