When did FDA first approve semaglutide, under which NDAs and brand names, and what indications were added later? Cite Drugs@FDA.

FDA first approved semaglutide on 5 December 2017, as Ozempic injection for type 2 diabetes under NDA 209637 (Novo Nordisk) ^[1][2]. Semaglutide is now sold under four brand names across three NDAs. Later approvals added cardiovascular and kidney indications for the diabetes products, plus obesity, adolescent obesity and MASH under the Wegovy brand.

Approach: NDA numbers, brands and product approval dates come from the FDA Orange Book and CDER's Novel Drug Approvals list. The indication supplements come from Drugs@FDA approval letters, labels and FDA announcements found by web search. The Drugs@FDA submission history isn't in the datasets I can search, so I read those dates from search snippets, not full documents. Treat any date I don't attribute to the Orange Book as approximate.

Original approvals by NDA

NDA	Brand(s)	Form	First approval	Later products
209637	Ozempic	Subcutaneous injection	5 Dec 2017 (2 mg/1.5 mL pen, now discontinued) [2]	4 mg/3 mL pen, 9 Apr 2019 [3]; 8 mg/3 mL, 28 Mar 2022 [4]; 2 mg/3 mL, 6 Oct 2022 [5]; single-dose 0.25, 0.5 and 1 mg, 5 May 2026 [6][7][8]
213051	Rybelsus; later also Ozempic (tablets)	Oral tablet	Rybelsus 3, 7 and 14 mg, 20 Sep 2019 [9][10][11]	1.5, 4 and 9 mg tablets listed under the trade name OZEMPIC, dated 9 Dec 2024 [12][13][14]
215256	Wegovy, Wegovy HD, Wegovy FlexTouch	Subcutaneous injection	0.25 to 2.4 mg, 4 Jun 2021 [15][16]	Wegovy HD 7.2 mg, 19 Mar 2026, with NS exclusivity to 19 Mar 2029 [17]; new 0.25 to 2.4 mg presentations, 5 May 2026 [18][19]; Wegovy FlexTouch 9.6 mg/3 mL, 18 Jun 2026 [20]
218316	Wegovy (tablets)	Oral tablet	1.5, 4, 9 and 25 mg, 22 Dec 2025, with NP exclusivity to 22 Dec 2028 [21][22]

The original 2017 Ozempic indication was: as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. The label also carried limitations of use: not first-line therapy, not studied in pancreatitis, not a substitute for insulin, and not for type 1 diabetes or diabetic ketoacidosis. It went through a standard review with no expedited designations ^[1].

Indications added later

Product / NDA	Added indication	When
Ozempic, NDA 209637 (supplement S-003)	Reduce the risk of major adverse cardiovascular events (MACE) in adults with type 2 diabetes and established cardiovascular disease	2020 approval letter
Wegovy, NDA 215256	Obesity in patients aged 12 years and older	December 2022
Wegovy, NDA 215256	Reduce the risk of cardiovascular death, heart attack and stroke in adults with cardiovascular disease and obesity or overweight	8 Mar 2024
Ozempic, NDA 209637	Reduce the risk of sustained eGFR decline, end-stage kidney disease and cardiovascular death in adults with type 2 diabetes and chronic kidney disease	28 Jan 2025
Wegovy, NDA 215256 (supplement S-024)	MASH (metabolic dysfunction-associated steatohepatitis) in adults with moderate-to-advanced liver fibrosis; accelerated approval with breakthrough designation, and keeping it depends on a confirmatory trial	August 2025
Rybelsus, NDA 213051 (supplements S-024, S-028, S-029)	Reduce the risk of MACE in adults with type 2 diabetes at high risk for these events	2025 approval letter

The Orange Book's new-indication exclusivities fit these dates:

• I-935 on Wegovy runs to 8 Mar 2027, matching the 8 Mar 2024 cardiovascular approval ^[16].
• I-961 on Ozempic runs to 28 Jan 2028, matching the 28 Jan 2025 kidney approval ^[5].
• I-973 on Wegovy runs to 15 Aug 2028 ^[16].
• I-976 on the NDA 213051 tablets runs to 17 Oct 2028 ^[11].

If I-973 and I-976 follow the same three-year pattern, the MASH approval would date to about 15 Aug 2025 and the Rybelsus cardiovascular approval to about 17 Oct 2025. That is an inference: the snippets I found give only "August 2025" and a 2025 letter.

Sources:

• Ozempic NDA 209637/S-003 approval letter (Drugs@FDA)
• Ozempic label 209637s035/s037 (Drugs@FDA)
• Wegovy label 215256s007 (Drugs@FDA)
• FDA: First treatment to reduce risk of serious heart problems in adults with obesity or overweight
• FDA: Approves treatment for MASH
• Wegovy NDA 215256/S-024 accelerated approval letter (Drugs@FDA)
• Rybelsus NDA 213051/S-024, S-028, S-029 approval letter (Drugs@FDA)