Proximagen, LLC: Nayzilam

Cosmetic Act for Nayzilam (midazolam) nasal spray 5 mg/0.5 mL.

We refer to our November 13, 2018, letter which identified Quality System deficiencies and requested additional information.

The deficiencies, identified in our November 13, 2018, letter, assumed that Proximagen was the applicant for NDA 211321, and that © was the contract manufacturer.

Based on your, March 8, 2019, Response to the March 5, 2019, FDA-483 that FDA issued to you, it appears that UCBBioPharma SPRL (UCB) has purchased this NDA and is integrally involved in several aspects of the Quality System at your firm.

You will need to update your responses to FDA's November 8, 2019, Quality System deficiencies to additionally identify how the manufacturer UCB integrates into the Quality System established at your firm.

If you include any proposed revisions to the labeling, in your resubmission in response to this letter, use the versions appended to this letter as the base documents with any revisions shown as tracked changes.