Wegovy label consolidates injection and tablet into one prescribing information
The FDA-approved Wegovy prescribing information now covers both the weekly injection and a 25 mg once-daily tablet in one document, with different dosing schedules and different approved uses for each form [1].
Novo Nordisk's Wegovy label, posted on DailyMed with a June 18, 2026 update, now covers two different products under one set of prescribing instructions: Wegovy (semaglutide) injection for subcutaneous use and Wegovy (semaglutide) tablets for oral use [1]. The document lists an initial U.S. approval year of 2017 and is filed as a New Drug Application label packaged by Novo Nordisk Pharmaceutical Industries, LP [1].
The two forms do not carry identical approved uses. The injection is indicated, along with a reduced-calorie diet and increased physical activity, to reduce the risk of major adverse cardiovascular events — cardiovascular death, non-fatal heart attack, or non-fatal stroke — in adults with established cardiovascular disease plus obesity or overweight; to reduce excess body weight and maintain that reduction long term in adults and pediatric patients aged 12 and older with obesity, and in adults with overweight plus at least one weight-related condition; and for noncirrhotic MASH with moderate to advanced liver fibrosis (stages F2 to F3) in adults, an indication granted under accelerated approval based on improvement of MASH and fibrosis [1].
The tablets are indicated only for cardiovascular risk reduction in adults with established cardiovascular disease and obesity or overweight, and for weight reduction and maintenance in adults with obesity or overweight with at least one weight-related condition [1]. The pediatric and MASH indications are not listed for the tablet [1].
Two dosing schedules in one document
The escalation schedules differ. The injection starts at 0.25 mg once weekly for 4 weeks, then titrates every 4 weeks, with a usual recommended maintenance dosage of 2.4 mg once weekly; the label notes that maintenance dosages vary by indication and directs readers to the full prescribing information [1]. The tablet starts at 1.5 mg once daily for 30 days and titrates every 30 days, with a recommended maintenance dosage of 25 mg once daily for cardiovascular risk reduction and weight reduction in adults [1].
The tablet also carries administration rules the injection does not. It is taken once daily on an empty stomach in the morning with water, up to 4 ounces, and no other liquids; tablets are swallowed whole and not split, crushed, chewed, or dissolved; and patients are instructed to wait at least 30 minutes after the tablet before eating, drinking other beverages, or taking other oral medicines [1]. The injection can be given on the same day each week at any time of day, with or without meals, in the abdomen, thigh, or upper arm [1].
Available strengths are listed for both. Injection: 0.25 mg, 0.5 mg, 1 mg, 1.7 mg, 2.4 mg, or 7.2 mg (Wegovy HD) in single-dose pens; 0.25 mg through 2.4 mg in single-dose syringes; and a 9.6 mg/3 mL single-patient-use Wegovy FlexTouch pen that delivers four 2.4 mg doses [1]. Tablets come in 1.5 mg, 4 mg, 9 mg, and 25 mg [1].
A limitation of use applies to both: taking Wegovy tablets or injection together with other semaglutide-containing products, or with any other GLP-1 receptor agonist, is not recommended [1].
Why it matters for patients
For the first time, an oral and an injectable version of the same weight-management medicine are governed by a single label, so a prescription decision between pill and pen now hinges on details in one document rather than two [1]. Practically, the approved population is narrower for the pill: a 13-year-old with obesity or an adult with F2–F3 MASH falls outside the tablet's listed indications [1].
The shared safety language still applies to both. The boxed warning about thyroid C-cell tumors seen in rodents remains, along with contraindications in people with a personal or family history of medullary thyroid carcinoma or MEN 2, and warnings covering pancreatitis, gallbladder disease, hypoglycemia when combined with insulin or insulin secretagogues, acute kidney injury from volume depletion, severe gastrointestinal reactions, and hypersensitivity [1]. The label says Wegovy is not recommended in patients with severe gastroparesis [1].
What happens next
The label's "Recent Major Changes" list shows steady revisions: indications in 08/2025 and 12/2025; dosage and administration in 08/2025, 12/2025, and 03/2026; severe gastrointestinal reactions in 10/2025; removal of the suicidal behavior and ideation section in 02/2026; and a new "Never Share WEGOVY FlexTouch Between Patients" section in 06/2026 [1]. Continued approval of the MASH indication may depend on a confirmatory trial verifying clinical benefit; the timing of that trial is not stated in the label [1].
Sources
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