Tools / Markets / Companies Ono Pharmaceutical Pharmaceutical company. FDA files no records under this name; these are its 1 companies' records, each linked to the record.
As of Nov 15, 2026, FDA's public records list Ono Pharmaceutical and its 1 subsidiaries with 2 drug applications.
Group recordsAI Labelled by a language model (which subsidiaries belong to the group) from the firm's FDA names. It is not an FDA field. : 2 , 2 entitiesDrug applications : 2 Records by Year Share Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Ono Pharmaceutical and its 1 subsidiaries
How to read this A hatched bar is a year that is not over, so its count covers only part of the year.
0 2017 0
0 2018 2018 0 vs 2017+0
0 2019 0 vs 2018+0
1 2020 2020 1 vs 2019+1
0 2021 0 vs 2020−1
0 2022 2022 0 vs 2021+0
0 2023 0 vs 2022+0
0 2024 2024 0 vs 2023+0
1 2025 1 vs 2024+1
0 2026 2026 to date 0
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Subsidiaries and Divisions 1 firms in the Ono Pharmaceutical group, most records first Payments to Doctors (Open Payments) What this company reported paying US doctors and teaching hospitals each year; see every company 2025: $26.0M General $0.4M · Research $25.6M 2024: $21.9M General $0.6M · Research $21.3M 2023: $13.5M General $0.6M · Research $12.8M 2022: $19.9M General $0.5M · Research $19.5M 2021: $41.8M General $0.4M · Research $41.4M 2020: $11.6M General $0.1M · Research $11.5M Orphan Designations (FDA) 7 designations since 1983, 1 approved for the designated use, matched by the sponsor's name; see all orphan designations Medicines Authorised in the EU (EMA) 2 medicines, 2 of them new active substances, matched by the authorisation holder's name; see all EU approvals Romvimza New substance · vimseltinib · Sep 17, 2025 Qinlock New substance · ripretinib · Nov 18, 2021 Approvals in Japan (PMDA) 60 approvals since 2008, 14 of them new active ingredients, matched by the Japanese company's name; see all Japanese approvals Braftovi Change · Encorafenib · Nov 20, 2025 Opdivo Change · Nivolumab (genetical recombination) · Aug 25, 2025 Opdivo Change · Nivolumab (genetical recombination) · Jun 24, 2025 Opdivo Change · Nivolumab (genetical recombination) · Dec 27, 2024 Braftovi Change · Encorafenib · May 17, 2024 Mektovi Change · Binimetinib · May 17, 2024 Opdivo Change · Nivolumab (genetical recombination) · Feb 9, 2024 Opdivo Change · Nivolumab (genetical recombination) · Nov 24, 2023
Canada and Imports Across the Ono Pharmaceutical group, matched by company name FDA import refusals since 2024 2 shipment lines, through Oct 23, 2026
Names and Identifiers
Appears as Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
