FDA approves Bydureon, the first once-weekly GLP-1, under NDA 022200

On January 27, 2012, the US Food and Drug Administration approved Bydureon, making extended-release exenatide the first GLP-1 receptor agonist that people can inject once a week instead of daily. The approval was issued under new drug application NDA 022200.

Bydureon is a long-acting form of exenatide built on microspheres, a delivery design that releases the drug over an extended period rather than in a single short burst. Before this approval, GLP-1 receptor agonist therapy in the United States was given by daily injection. The once-weekly version changed that schedule for the class.

An FDA approval is not permanent, and the agency's handling of older applications shows how that works. The FDA can withdraw approval of a new drug application when a product is no longer being marketed and the applicant asks the agency to act. In a notice published August 4, 2025, the FDA said it was withdrawing approval of 39 new drug applications from multiple applicants, effective September 3, 2025, after the companies told the agency the products were no longer marketed and requested withdrawal ^[1]. The applicants also waived their opportunity for a hearing ^[1]. The notice states that a withdrawal under this process is without prejudice to refiling, so an applicant could seek approval again later ^[1].

That notice did not explain why any individual product stopped being sold beyond the statement that it was no longer marketed ^[1]. It also did not discuss once-weekly exenatide or NDA 022200, and the current US marketing status of Bydureon has not been reported. Details such as the launch price, launch date and any post-approval study commitments tied to the 2012 decision were not disclosed in the regulatory material described here.

Why it matters for patients

Once-weekly injection is now the default schedule for much of the GLP-1 class that followed Bydureon. The class today includes semaglutide (sold as Ozempic, Wegovy and Rybelsus), tirzepatide (Mounjaro and Zepbound) and the oral orforglipron (Foundayo). These are separate molecules with their own FDA-approved labeling, not forms of exenatide.

For anyone weighing a GLP-1 medicine, the practical point is that dosing frequency is a design choice, not a fixed feature of the class. A weekly injection means fewer needle events per month than a daily one, which some patients find easier to fit into a routine. It also means that if a dose is missed, the timing of the next injection and any instructions for catching up come from that product's own prescribing information, not from a general rule for GLP-1 drugs.

Switching between products is not a simple matter of matching weekly to weekly. Exenatide extended-release, semaglutide, tirzepatide and orforglipron differ in molecule, dose, titration schedule and approved uses. Prescribing information for each product is the place where those differences are spelled out. Nothing in the 2025 withdrawal notice changes the approved labeling of any GLP-1 medicine still on the market ^[1].

What happens next

The withdrawal of the 39 applications took effect September 3, 2025 ^[1]. A correction to that notice published October 3, 2025 ^[1]. No further FDA action on once-weekly exenatide dosing, or on NDA 022200, has been announced in the regulatory material described here.