Eton Pharmaceuticals (NASDAQ:ETON) announces that its partner [a subsidiary of Bausch Health Companies (NYSE:BHC) per a February 19 press release] received a Complete Response Letter (CRL) from the FDA regarding the partner’s marketing application seeking approval for EM-100, an eye drop for the potential treatment of ocular itching associated with allergic conjunctivitis.
Eton says the CRL did not cite the need for additional clinical data but offered no additional information other than stating that a response will be submitted shortly, adding that it remains confident that the agency will approve the product.
The Bausch subsidiary acquired the U.S. rights to EM-100 in February.
ETON is down 13% after hours.
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