Aldeyra Therapeutics · reproxalap · Dec 2025 – Mar 2026

Was the FDA negotiating reproxalap's label when it issued the second letter?

Aldeyra says the FDA sent draft labels in December 2025 and March 2026. The letter reserves comment on the proposed labeling “until the application is otherwise adequate”.

EphemerisX Research · Published · 5 source documents · 1 min read

Short answer

Label drafts were exchanged, by Aldeyra's account: the FDA shared a draft in early December 2025 and another in March 2026, and Aldeyra does not believe negotiations were completed. The March 16, 2026 letter, like the 2025 letter, reserves comment on the proposed labeling until the application is otherwise adequate.

What the evidence shows

December 2025: In early December, the FDA shared with Aldeyra a draft of the prospective label, and Aldeyra has submitted a response 8-K · Dec 16, 2025. And: The FDA notified Aldeyra that if no major deficiencies are identified during the extended review, the FDA plans to communicate proposed labeling requests and, if necessary, any anticipated postmarketing requirements by February 16, 2026 8-K · Dec 16, 2025. The 10-K repeats it: In early December 2025, a draft label was received from the FDA 10-K · Feb 27, 2026.

March 2026, after the letter: During the NDA review, label drafts were provided by the FDA in December 2025 and again in March 2026 8-K · Mar 17, 2026. Aldeyra does not believe that label negotiations were completed 8-K · Mar 17, 2026.

The letter, on page 2: CARTON AND CONTAINER LABELING We reserve comment on the proposed labeling until the application is otherwise adequate FDA · Mar 16, 2026 · p. 2. Of the proposed proprietary name: This name was found conditionally acceptable pending approval of the application in the current review cycle FDA · Mar 16, 2026 · p. 2. The 2025 letter used the same wording on labeling: We reserve comment on the proposed labeling until the application is otherwise adequate FDA · Apr 2, 2025 · p. 2.

Not in this record: the draft labels, the FDA's labeling communications, and whether proposed labeling requests were sent by February 16, 2026.

Follow the thread

The documents, by date

FDA Complete Response Letter, April 2, 2025FDA letter · Apr 2, 2025Aldeyra Therapeutics Form 8-K, filed December 16, 20258-K · Dec 16, 2025Aldeyra Therapeutics Form 10-K, filed February 27, 202610-K · Feb 27, 2026FDA Complete Response Letter, March 16, 2026FDA letter · Mar 16, 2026Aldeyra Therapeutics Form 8-K, filed March 17, 20268-K · Mar 17, 2026

The passages quoted

FDA Complete Response Letter, April 2, 2025 · page 2

PRESCRIBING INFORMATION We reserve comment on the proposed labeling until the application is otherwise adequate.
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Aldeyra Therapeutics Form 8-K, filed December 16, 2025

In early December, the FDA shared with Aldeyra a draft of the prospective label, and Aldeyra has submitted a response. The FDA notified Aldeyra that if no major deficiencies are identified during the extended review, the FDA plans to communicate proposed labeling requests and, if necessary, any anticipated postmarketing requirements by February 16, 2026.
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Aldeyra Therapeutics Form 10-K, filed February 27, 2026

In early December 2025, a draft label was received from the FDA. On December 15, 2025, the day before the target action PDUFA date for the second NDA resubmission, we announced that the FDA requested that the field trial be submitted to the NDA, triggering a three-month extension of the PDUFA target action date to March 16, 2026.
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FDA Complete Response Letter, March 16, 2026 · page 2

CARTON AND CONTAINER LABELING We reserve comment on the proposed labeling until the application is otherwise adequate.
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FDA Complete Response Letter, March 16, 2026 · page 2

This name was found conditionally acceptable pending approval of the application in the current review cycle. Please resubmit the proposed proprietary name when you respond to all of the application deficiencies that have been identified in this letter.
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Aldeyra Therapeutics Form 8-K, filed March 17, 2026

During the NDA review, label drafts were provided by the FDA in December 2025 and again in March 2026. Aldeyra does not believe that label negotiations were completed.
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Prepared from public FDA letters and SEC filings: every quoted passage is matched to the original document, and every “not in” statement comes from a search of the whole document, before it is published. Questions, summaries and connecting sentences are EphemerisX’s wording. Not investment advice. How this research works → · Ask the FDA and SEC Ephemeris →