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From: Smith, Michael (CBER)
Sent: Tuesday, July 6, 2021 9:00 AM
To: Harkins Tull, Elisa <[email protected]>; Aghajani Memar, Neda
<[email protected]>; Devlin, Carmel M <[email protected]> Cc: Naik, Ramachandra <[email protected]>; Gottschalk, Laura
<[email protected]>
Subject: STN 125742.0: Your proposed proprietary name, COMIRNATY, is Acceptable
Elisa,
In consultation with CBER’s Advertising and Promotional Labeling Branch, we
conclude that under the Federal Food, Drug, and Cosmetic Act and applicable
regulations your proposed proprietary name, COMIRNATY , is Acceptable.
Regards,
Mike
- Please confirm receipt of this e -mail.
Mike Smith, Ph.D.
Captain, USPHS
Senior Regulatory Review Officer
Food and Drug Administration
Center for Biologics Evaluation & Research
Offic e of Vaccines Research & Review
Division of Vaccines and Related Products Applications Tel: 301- 796-2640
[email protected]
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hone.
FDA-CBER-2021-5683-1024819