The FDA has rejected Eton Pharmaceuticals’ EM-100 for the treatment of ocular itching associated with allergic conjunctivitis, according to a press release.
Eton’s partner, Bausch Health Companies, which acquired the U.S. rights to EM-100 in February, received a complete response letter from the FDA regarding the filing.
The letter did not raise concerns about the clinical data, leaving the company optimistic about EM-100’s future.
“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
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