FDA approves Ozempic, the first semaglutide product

The U.S. Food and Drug Administration approved Ozempic (semaglutide) injection on December 5, 2017, as an add-on to diet and exercise to improve blood sugar control in adults with type 2 diabetes ^[1][4]. It was the first approved product containing semaglutide, and FDA classified the application, NDA 209637 from Novo Nordisk, as a "Type 1 - New Molecular Entity" — the agency's designation for a drug whose active ingredient has never been approved before ^[4].

The approval came almost exactly a year after Novo Nordisk filed the application on December 5, 2016 ^[1]. An FDA advisory committee voted 16-0 in favor of approval on October 18, 2017 ^[1]. FDA posted the original product label on December 6, 2017 and the approval letter on December 7, 2017 ^[4].

What the drug is and how it is given

Semaglutide is an analog of glucagon-like peptide-1 (GLP-1), a naturally occurring hormone. It binds to and activates the GLP-1 receptor, stimulating insulin secretion and lowering glucagon secretion when blood glucose is high ^[1]. Ozempic is injected under the skin once weekly, at any time of day, with or without meals, into the abdomen, thigh, or upper arm ^[1][3].

The label describes a step-up schedule: starting at 0.25 mg once weekly, increasing to 0.5 mg after 4 weeks, and moving to 1 mg after at least 4 more weeks if more glucose control is needed ^[3]. A higher 2 mg weekly dose was not part of the 2017 approval; FDA cleared it on March 28, 2022 ^[1].

Safety information in the label

Ozempic carries a boxed warning for risk of thyroid C-cell tumors. The warning states that semaglutide causes thyroid C-cell tumors in rodents, and that it is unknown whether Ozempic causes such tumors, including medullary thyroid carcinoma (MTC), in humans, because the human relevance of the rodent findings has not been determined ^[3]. The drug is contraindicated in people with a personal or family history of MTC or with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2), and in people with a serious hypersensitivity reaction to semaglutide or the product's other ingredients ^[3].

Other labeled warnings include acute pancreatitis, diabetic retinopathy complications, hypoglycemia when used with insulin or insulin secretagogues, and acute kidney injury from volume depletion ^[1][3]. The most common side effects reported in 5% or more of patients are nausea, vomiting, diarrhea, abdominal pain, and constipation ^[3]. Because Ozempic slows stomach emptying, the label says it may affect absorption of other oral medicines and should be used with caution alongside them ^[3].

Why it matters for patients

This approval put a once-weekly injectable GLP-1 option on the U.S. market for type 2 diabetes and created the molecule that later became the basis for several widely used products. For someone with type 2 diabetes in 2017, the practical points were the weekly injection schedule, the gradual dose increase built into the label, and the boxed warning and contraindications tied to thyroid tumor risk in animals ^[1][3].

The 2017 approval covered blood sugar control only. Ozempic was not approved for weight loss, heart protection, or kidney protection at that time; those uses were added later through separate FDA decisions ^[1].

What happens next

FDA has since expanded semaglutide across indications and dosage forms. Rybelsus, an oral semaglutide tablet for type 2 diabetes, was approved September 20, 2019 ^[1]. Ozempic added a cardiovascular risk-reduction indication for adults with type 2 diabetes and known heart disease on January 16, 2020 ^[1]. Wegovy, the semaglutide injection for weight management, was approved June 4, 2021 ^[1]. On January 28, 2025, FDA approved Ozempic to reduce the risk of worsening kidney disease and cardiovascular death in adults with type 2 diabetes and chronic kidney disease ^[1].

One inconsistency is worth noting: an FDA announcement about Wegovy's approval for the liver disease MASH states that Wegovy was "first approved in 2017" ^[2], while the approval-history record lists Wegovy's first approval as June 4, 2021 and December 5, 2017 as the date for Ozempic ^[1]. The 2017 date corresponds to Ozempic.