FDA approves Ozempic brand name for Novo's oral semaglutide diabetes pill

The FDA has approved Ozempic as the brand name for Novo Nordisk's oral semaglutide for type 2 diabetes, and the company is retiring Rybelsus in the United States ^[1][4]. The approval letter carries an electronic signature dated Jan. 30, 2026, and Novo announced the change on Feb. 4 ^[1][2][3].

The renamed medicine comes as Ozempic tablets in 1.5 mg, 4 mg and 9 mg strengths for adults with type 2 diabetes ^[2][3]. Rybelsus had been sold in 3 mg, 7 mg and 14 mg tablets ^[3]. Novo said the FDA cleared the new doses based on a bioequivalence study and on the clinical trial data already collected for Rybelsus ^[3].

The tablet itself also changed. It is smaller and has a new coating ^[4]. Michael Radin, Novo's executive director of diabetes medical affairs, said the reformulation improved absorption, which allowed lower milligram strengths to deliver the same effect ^[4]. Fierce Pharma reported that the old 3 mg, 7 mg and 14 mg Rybelsus doses correspond to the new 1.5 mg, 4 mg and 9 mg Ozempic tablets, in that order ^[4].

One detail in the public discussion does not line up. An HCPLive Diabetes Dialogue segment described the approval as covering 14 mg oral semaglutide now branded as Ozempic, while Fierce Pharma reported that the top strength of the new tablet is 9 mg ^[2][4]. The FDA approval letter does not list tablet strengths ^[1].

The active ingredient is unchanged. It is semaglutide, the same molecule used in injectable Ozempic, so this is a rebrand plus a reformulation rather than a new drug ^[2][4]. Rybelsus made history in 2019 as the first GLP-1 medicine approved in pill form ^[4]. Beyond blood sugar control, the oral product is also approved to reduce the risk of certain cardiovascular conditions in adults with type 2 diabetes who are at high risk for those events ^[3].

Rybelsus branding ends in the U.S., and the company said the switch would be handled across the year ^[4]. "The Rybelsus brand won't be carried forward but the tablets will continue under the iconic brand of Ozempic," Ed Cinca, Novo's senior vice president of marketing and patient solutions, told Fierce Pharma ^[4]. The new pill started rolling out Monday, May 4, through roughly 70,000 brick-and-mortar pharmacies and Novo's NovoCare direct-to-patient pharmacy ^[4]. Novo said the oral format is made end-to-end in the United States, largely at its North Carolina operations, and that it is confident about supply ^[4]. The change is U.S.-only; Rybelsus remains the brand sold in other countries ^[4]. Oral semaglutide for weight management is marketed separately, as the Wegovy pill ^[4]. Lilly sells the rival oral GLP-1 Foundayo, made from orforglipron, and its tirzepatide products Mounjaro and Zepbound compete with Novo's injectables ^[4].

Why it matters for patients

Someone picking up a refill may see a different name on the box even though the medicine is semaglutide ^[2][4]. Novo's guidance to people already taking Rybelsus is to keep using their medication as directed and to talk with their prescriber about moving to the Ozempic pill when appropriate ^[4].

How the tablet is taken has not changed. It must be swallowed with no more than four ounces of water and kept apart from other medications because of an ingredient that helps absorption ^[2]. It is a once-daily pill, but its half-life is about one week, similar to injectable GLP-1s, and clinicians note that timing matters around pregnancy planning and surgery ^[2].

Whether insurance coverage, prior authorization rules or out-of-pocket costs shift with the new name has not been reported. Clinicians who discussed the rebranding said putting oral and injectable products under one brand could cut confusion and ease prior authorizations, which they described as an expectation rather than a measured result ^[2]. The same discussion pointed to a rise in patient questions about oral semaglutide, which the participants linked to the new name ^[2].

Because the change applies only in the U.S., the identical medicine can carry a different label abroad, which matters for anyone filling prescriptions while traveling ^[4].

What happens next

• Novo expects an FDA decision on a 25 mg Ozempic tablet dose by the end of 2026 ^[3].
• The company said the transition from Rybelsus branding would play out over the course of the year ^[4].
• Novo said it is relying on U.S. manufacturing, mainly in North Carolina, and described itself as confident about supply of both the Ozempic pill and the Wegovy pill ^[4].