Government ContextGovernment Context
ActivityRulesGrantsPress releasesHearingsBills
ViewsAgenciesTopicsOrganizationsCommitteesLegislators
PricingLog inCreate account
Nonrulemaking

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mL), approved under New Drug Application (“NDA”) number 205776, held by Medexus Pharma Inc., has been voluntarily withdrawn for reasons of safety or effectiveness

🏛 Food and Drug Administration (FDA)FDA-2026-P-4232
Pharmaceutical Policy
Documents
3
Total comments
0
all analyzed
Comment status
Closed
Last activity
—
In this docket

Documents

Rules, notices, and supporting material — the primary rule pinned first.

All 3Other 2Notice 1
📄 Primary document
OtherJul 22, 2026
Final Response Letter from FDA CDER to Hyman, Phelps & McNamara, P.C.
No comment period
Open →