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Contepo (fosfomycin disodium)

New active ingredientPriority review
Region
🇺🇸 US
Active substance
fosfomycin disodium
Company
Meitheal
Status
Approved
FDA approval
Wed 22 Oct 2025
Designations
New active ingredient, Priority review
Application
NDA212271
Official record
www.accessdata.fda.gov

Regulatory milestones

Wed 22 Oct 2025🇺🇸 FDA approval

FDA approves Contepo (fosfomycin disodium): new active ingredient

Meitheal; NDA212271; New active ingredient, Priority review; powder · source

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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.