October 29, 2024, Covington Alert

This e-alert is part of a series of e-alerts summarizing publicly available FDA enforcement letters (i.e., warning letters and untitled letters) relating to the advertising and promotion of prescription drugs, medical devices, and biologics.

During the third quarter of 2024 FDA’s Office of Prescription Drug Promotion (OPDP) posted the following three untiled letters.

• Untitled Letter to AbbVie, Inc. re NDA 211765 UBRELVY (ubrogepant) tablets, for oral use (August 29, 2024) (Ubrelvy Untitled Letter)
• Untitled Letter to Mirati Therapeutics Inc. (a Bristol Myers Squibb Co.) re NDA 216340 KRAZATI™ (adagrasib) tablets, for oral use MA 166 (August 1, 2024) (Krazati Untitled Letter)
• Untitled Letter to Kaleo, Inc. re NDA 201739 AUVI-Q® (epinephrine injection, USP), for intramuscular or subcutaneous use MA 1021 (July 17, 2024) (Auvi-Q Untitled Letter)

The Office of Product Evaluation and Quality (OPEQ) at the Center for Devices and Radiological Health (CDRH) and the Office of Medical Device and Radiological Health Operations (OMDRHO) in the Office of Regulatory Affairs (ORA) did not post any warning letters relating to the advertising and promotion of medical devices during this period. FDA’s Advertising and Promotional Labeling Branch (APLB) in the Office of Compliance and Biologics Quality (OCBQ) has not posted any enforcement letters since 2018.

This alert merely summarizes the allegations contained in FDA’s letters. It does not contain any analyses, opinions, characterizations, or conclusions by or of Covington & Burling LLP. As a result, the information presented herein does not necessarily reflect the views of Covington & Burling LLP or any of its clients.Continue Reading FDA Advertising and Promotion Enforcement Activities: Update