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FDA NDA · NDA211155

COPIKTRA

duvelisib

Sponsor: SECURA

APPLICATION
NDA211155
TYPE
NDA
ORIGINAL APPROVAL
2018-09-24
LATEST ACTION
2025-10-24
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

COPIKTRA · ReferencePrescription
DUVELISIB 25MG · CAPSULE · ORAL
COPIKTRA · ReferencePrescription
DUVELISIB 15MG · CAPSULE · ORAL

Approval history

2025-10-24REMS · Supplement 9 — Letter ↗AP
2025-07-28REMS · Supplement 8 — Letter ↗AP
2024-07-26Labeling · Supplement 7 · standard — Letter ↗AP
2022-02-02REMS · Supplement 6 — Letter ↗AP
2021-12-17Labeling · Supplement 5 · standard — Label ↗AP
2021-09-22Labeling · Supplement 3 · standard — Label ↗AP
2019-09-26Labeling · Supplement 1 · standard — Letter ↗AP
2018-09-24Efficacy · Original · priority — Letter ↗AP
2018-09-24Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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