Federal Register #FDA-2026-N-10606

FDA Advisory Committee Meeting Notice for Atropine Sulfate Ophthalmic Solution, 0.01% (NDA 219694)

This notice from the Food and Drug Administration (FDA), under the Department of Health and Human Services, announces a public advisory committee meeting regarding a new drug application: - Government Buyer: - Food and Drug Administration (FDA) - Department of Health and Human Services - OEMs and Vendors: - Sydnexis, Inc. (applicant for the drug) - Products/Services Requested: - No procurement of products or services is requested - Discussion centers on New Drug Application (NDA) 219694 for atropine sulfate ophthalmic solution, 0.01% - Unique or Notable Requirements: - The drug is proposed for slowing myopia progression in children aged 3 years and older - The FDA is soliciting public comments via a docket - The notice is for regulatory review and public engagement, not procurement - No purchase quantities, part numbers, or contract requirements are specified - No services or products are being solicited for purchase

Description

The Food and Drug Administration (FDA) announces a public advisory committee meeting of the Dermatologic and Ophthalmic Drugs Advisory Committee to provide advice and recommendations on regulatory issues related to dermatologic and ophthalmic drugs. The meeting will discuss New Drug Application (NDA) 219694 for atropine sulfate ophthalmic solution, 0.01%, intended for slowing myopia progression in children aged 3 years and older. The meeting is open to the public and will be held on October 30, 2026, from 8:30 a.m. to 3 p.m. Eastern Time. FDA is establishing a docket for public comment on this document, with comments closing on October 30, 2026.

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