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Did the FDA approve Reproxalap, the AbbVie dry eye disease drug?

Asked by Anonymous Sep 02, 2026 0 views 1 answers
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Answered Sep 02, 2026

No, Reproxalap is developed and owned by Aldeyra Therapeutics, not AbbVie. The U.S. Food and Drug Administration (FDA) did not grant immediate approval for the drug's New Drug Application, instead issuing Complete Response Letters citing a need for further evidence regarding clinical trial endpoints and efficacy demonstrations under proposed labeling conditions, prompting Aldeyra to pursue further collaborative meetings with regulatory bodies.

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