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Aldeyra announces FDA acceptance of ocular reproxalap NDA
The Fly

Aldeyra announces FDA acceptance of ocular reproxalap NDA

Aldeyra announced that the FDA has accepted the new drug application, or NDA, for topical ocular reproxalap, a first-in-class investigational new drug candidate, for the treatment of the signs and symptoms of dry eye disease. The FDA assigned a Prescription Drug User Fee Act, or PDUFA, date of November 23. The FDA noted that no potential filing review issues have been identified, and that an advisory committee meeting is not currently planned.

Published first on TheFly

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