Olumiant

NDA 207924, held by Eli Lilly And Co. Baricitinib.

As of Nov 14, 2026, NDA 207924 (Olumiant), held by Eli Lilly And Co, was first approved by FDA on May 31, 2018, with 8 approved supplements and 0 published complete response letters.

First approved: May 31, 2018
Review: Standard
Supplements approved: 8
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

OLUMIANT is a Janus kinase (JAK) inhibitor indicated for the treatment of: Moderately to severely active rheumatoid arthritis (RA) in adults who have had an inadequate response to one or more TNF blockers. Limitations of Use: Not recommended for use in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine. COVID-19 in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO. Severe alopecia areata (AA) in adults and pediatric patients 12 years of age and older.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below


Oct 9, 2026	Supplement 10Efficacy (new indication or use) · Standard review	Approved	Label Medication Guide Letter
Sep 25, 2026	Supplement 9Efficacy (new indication or use) · Standard review	Approved	Label Medication Guide Letter
Jun 13, 2022	Supplement 7Efficacy (new indication or use) · Priority review	Approved	Label Letter
May 10, 2022	Supplement 6Efficacy (new indication or use) · Priority review	Approved	Letter Label Medication Guide
Oct 8, 2019	Supplement 1Efficacy (new indication or use) · Standard review	Approved	Letter Label
May 31, 2018	Original applicationNew molecular entity · Standard review	Approved	Review Label Letter

Products

3 strengths and forms


Olumiant2MG · tablet;oral	Baricitinib	RxReference drug
Olumiant1MG · tablet;oral	Baricitinib	RxReference drug
Olumiant4MG · tablet;oral	Baricitinib	RxReference drug

All 9 submissions, including labeling and manufacturing supplements


Oct 9, 2026	Supplement 10Efficacy (new indication or use) · Standard review	Approved	Label Medication Guide Letter
Sep 25, 2026	Supplement 9Efficacy (new indication or use) · Standard review	Approved	Label Medication Guide Letter
Jun 30, 2026	Supplement 11Labeling · Standard review	Approved	Label Letter
Jun 13, 2022	Supplement 7Efficacy (new indication or use) · Priority review	Approved	Label Letter
May 10, 2022	Supplement 6Efficacy (new indication or use) · Priority review	Approved	Letter Label Medication Guide
Dec 2, 2021	Supplement 4Labeling · Standard review	Approved	Label Letter
Jul 8, 2020	Supplement 2Labeling · Standard review	Approved	Letter Label
Oct 8, 2019	Supplement 1Efficacy (new indication or use) · Standard review	Approved	Letter Label
May 31, 2018	Original applicationNew molecular entity · Standard review	Approved	Review Label Letter

Identifiers

Application: NDA 207924
Drugs@FDA: Overview at FDA
Company: Eli Lilly

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters