Requests that FDA determine whether RASUVO (methotrexate) Injection, 27.5 mg/0.55 mL (27.5 mg/0.55 mL), approved under New Drug Application (“NDA”) number 205776, held by Medexus Pharma Inc., has been voluntarily withdrawn for reasons of safety or effectiveness | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

FDA-2026-P-4232

Requests that FDA determine whether RASUVO (methotrexate) Injection, 27.5 mg/0.55 mL (27.5 mg/0.55 mL), approved under New Drug Application (“NDA”) number 205776, held by Medexus Pharma Inc., has been voluntarily withdrawn for reasons of safety or effectiveness

Documents

Comments

Description

CLOSED

Key Dates

Comment Period OpensApr 21, 2026

Documents

Type	Title	Posted	Comments	Status
Other	Final Response Letter from FDA CDER to Hyman, Phelps & McNamara, P.C.	Jul 22, 2026	--

Keywords

CDER

Citizen Petition

Hyman, Phelps & McNamara, P.C.

Requests that FDA determine whether

RASUVO (methotrexate) Injection,

27.5 mg/0.55 mL (27.5 mg/0.55 mL),

approved under New Drug Application

(“NDA”) number 205776, held by

Data from Regulations.gov