FDA approves instructions for use for single-dose Ozempic prefilled syringe

The FDA has approved an Instructions for Use for a new single-dose prefilled syringe of Ozempic (semaglutide), the first version of the drug that is not a dial pen, according to the drug's updated prescribing information ^[1][2]. The label, revised 05/2026, now lists single-dose prefilled syringes in 0.25 mg, 0.5 mg and 1 mg per 0.5 mL alongside the existing pens ^[1][2].

What changed on the label

The new presentation is described as a single-dose prefilled glass syringe with an integrated needle, supplied four to a carton, with its own Instructions for Use marked approved 05/2026 ^[1]. Ozempic's other presentations are single-patient-use pens that hold multiple weekly doses, at 2 mg/3 mL (0.68 mg/mL), 4 mg/3 mL (1.34 mg/mL) and 8 mg/3 mL (2.68 mg/mL) ^[1][2].

The syringe tops out at 1 mg per injection. The 2 mg weekly dose, which the label lists as the maximum recommended dosage for glycemic control, remains available only in the pen ^[1].

Ozempic is indicated as an adjunct to diet and exercise to improve blood sugar in adults with type 2 diabetes, to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes and established cardiovascular disease, and to reduce the risk of sustained eGFR decline, end-stage kidney disease and cardiovascular death in adults with type 2 diabetes and chronic kidney disease ^[1].

The weekly dosing schedule itself is unchanged: 0.25 mg once weekly for 4 weeks, then 0.5 mg once weekly, with possible increases to 1 mg and then 2 mg after at least 4 weeks at each step ^[1]. Injections go under the skin of the abdomen, thigh or upper arm, using a different site each week when injecting in the same body region ^[1].

A different technique and a shorter storage window

Use of the prefilled syringe differs from the pens in ways a patient would notice at the kitchen table. The syringe is used with a pinched skinfold and a 45-degree angle rather than a dose counter that is dialed to a number ^[1]. The syringe also has a shorter in-use storage window: 28 days at 8 to 30 C, compared with 56 days for the pen ^[1].

The syringe addition and a 10/2025 update to the severe gastrointestinal adverse reactions warning appear in the same prescribing information, although the label's Recent Major Changes section lists only the October 2025 item ^[1][2].

Why it matters for patients

• Technique: A patient switching from a pen to the syringe would be learning a new injection method, and the product's own Instructions for Use is the document that describes it ^[1].
• Storage: A 28-day window at 8 to 30 C, rather than the pen's 56 days, changes how long an opened product can be kept and how much can be stored at a time ^[1].
• Dose ceiling: Because the syringe is listed only at 0.25 mg, 0.5 mg and 1 mg, anyone on the 2 mg weekly dose would still be using a pen ^[1].
• Sharing and reuse: The label says never to share an Ozempic pen between patients, even if the needle is changed ^[1]. A single-dose prefilled syringe is designed for one use and then disposal.
• Safety information is unchanged. Ozempic carries a boxed warning that semaglutide causes thyroid C-cell tumors in rodents, that it is unknown whether the drug causes such tumors, including medullary thyroid carcinoma, in humans, and that it is contraindicated in patients with a personal or family history of MTC or with Multiple Endocrine Neoplasia syndrome type 2 ^[1]. The most common adverse reactions reported in 5% or more of patients are nausea, vomiting, diarrhea, abdominal pain and constipation ^[1].

A launch date, price and insurance coverage for the prefilled syringe have not been disclosed in the prescribing information ^[1][2].

What happens next

The label carries a 05/2026 revision date, and the syringe's Instructions for Use is marked approved 05/2026 ^[1][2]. Whether the prefilled syringe will replace any existing pen presentation, how it will be priced, and how insurers will cover it have not been reported.