Aldeyra Therapeutics, Inc. · surat respons lengkap (NDA 216442)

Kutipan sumber

ADMINISTRATION ( Lg YN U.S. FOOD & DRUG NDA 216442 COMPLETE RESPONSE Aldeyra Therapeutics, Inc. Attention: David Noskowitz Regulatory Affairs Consultant 131 Hartwell Ave., Suite 320 Lexington, MA 02421 Dear David Noskowitz: Please refer to your new drug application (NDA) for Reproxalap Ophthalmic Solution, ©® . We acknowledge receipt of your amendment dated me) , which constituted a complete response to our oe , action letter. We acknowledge receipt of your major amendment dated oe , which extended the goal date by three months. We have completed our review of this application, as amended, and have determined that we cannot approve this application in its present form. We have described our reasons for this action below and, where possible, our recommendations to address these iss

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