Rasuvo

Manages severe, active rheumatoid arthritis (RA) and … idiopathic arthritis (pJIA). NDA 205776, held by Medexus. Methotrexate.

As of Nov 15, 2026, NDA 205776 (Rasuvo), held by Medexus, was first approved by FDA on Jul 10, 2014, with 3 approved supplements and 0 published complete response letters.

First approved: Jul 10, 2014
Review: Standard
Supplements approved: 3
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Rasuvo is a folate analog metabolic inhibitor indicated for the: Management of patients with severe, active rheumatoid arthritis (RA) and polyarticular juvenile idiopathic arthritis (pJIA), who are intolerant of or had an inadequate response to first-line therapy Symptomatic control of severe, recalcitrant, disabling psoriasis in adults who are not adequately responsive to other forms of therapy Limitation of Use Rasuvo is not indicated for the treatment of neoplastic diseases. 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Jul 10, 2014	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Letter Label

Products

10 strengths and forms


Rasuvo7.5MG/0.15ML (7.5MG/0.15ML) · solution;subcutaneous	Methotrexate	RxReference drug
Rasuvo10MG/0.20ML (10MG/0.20ML) · solution;subcutaneous	Methotrexate	RxReference drug
Rasuvo12.5MG/0.25ML (12.5MG/0.25ML) · solution;subcutaneous	Methotrexate	RxReference drug
Rasuvo15MG/0.30ML (15MG/0.30ML) · solution;subcutaneous	Methotrexate	RxReference drug
Rasuvo17.5MG/0.35ML (17.5MG/0.35ML) · solution;subcutaneous	Methotrexate	RxReference drug
Rasuvo20MG/0.4ML (20MG/0.4ML) · solution;subcutaneous	Methotrexate	RxReference drug
Rasuvo22.5MG/0.45ML (22.5MG/0.45ML) · solution;subcutaneous	Methotrexate	RxReference drug
Rasuvo25MG/0.5ML (25MG/0.5ML) · solution;subcutaneous	Methotrexate	RxReference drug
Rasuvo27.5MG/0.55ML (27.5MG/0.55ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · solution;subcutaneous	Methotrexate	DiscontinuedReference drug
Rasuvo30MG/0.6ML (30MG/0.6ML) · solution;subcutaneous	Methotrexate	RxReference drug

All 4 submissions, including labeling and manufacturing supplements


Mar 11, 2020	Supplement 4Labeling · Standard review	Approved	Letter Label
Mar 15, 2018	Supplement 2Labeling · Standard review	Approved	Letter Label
Aug 24, 2015	Supplement 1Labeling · Standard review	Approved	Letter Label
Jul 10, 2014	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 205776
Drugs@FDA: Overview at FDA
Company: Medexus Pharma

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