Drugs

FDA Denies Ozempic Petition Without Substantive Comment

To meet the legal requirement that it take final action on a petition within 150 days, FDA has denied without commenting on the specifics an 8/29/2025 petition submitted by Foley & Lardner asking for restrictions on approval for any ANDA citing Novo Nordisk’s Ozempic (semaglutide) as the reference-listed drug. “We deny without comment the specific requests in your petition regarding the approvability of any specific ANDA referencing Ozempic or the therapeutic equivalence determination of any specific semaglutide product approved pursuant to an application submitted under section 505(b)(2) that references Ozempic,” the denial letter says.

The agency says it has not made a final determination on whether to approve or not approve any ANDA referencing Ozempic, and also has not made a final determination on the therapeutic equivalence of any specific semaglutide product approved pursuant to an application submitted under section 505(b)(2) that references Ozempic.

“FDA’s decision to approve or not approve a specific application or make a therapeutic equivalence determination will be based on the particular facts that are applicable to that application at the time of the decision,” FDA says.

In its broadest form, the petition asked that FDA not approve an ANDA citing Ozempic injection as the reference-listed drug unless:

the generic drug/device combination product includes a pen injector that is functionally equivalent to Ozempic; and
if the semaglutide active pharmaceutical ingredient (API) is produced via intermediates, such as, but not limited to, P29, derived through a fermentation route, the API should be classified as a hybrid API, not a purely synthetic one with established adequate controls to reduce immunogenicity risk.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome