← FDA DRUG APPROVALS

FDA NDA · NDA205437

OTEZLA

apremilast

Sponsor: AMGEN INC

APPLICATION
NDA205437
TYPE
NDA
ORIGINAL APPROVAL
2014-03-21
LATEST ACTION
2025-12-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

OTEZLA · ReferencePrescription
APREMILAST 30MG · TABLET · ORAL
OTEZLA · ReferencePrescription
APREMILAST 10MG · TABLET · ORAL
OTEZLA · ReferencePrescription
APREMILAST 20MG · TABLET · ORAL

Approval history

2025-12-23Labeling · Supplement 16 · standard — Label ↗AP
2025-07-23Efficacy · Supplement 14 · standard — Letter ↗AP
2024-04-25Efficacy · Supplement 13 · priority — Letter ↗AP
2023-07-20Efficacy · Supplement 12 · standard — Letter ↗AP
2021-12-20Efficacy · Supplement 11 · standard — Letter ↗AP
2020-04-10Efficacy · Supplement 8 · standard — Letter ↗AP
2019-07-19Efficacy · Supplement 7 · standard — Label ↗AP
2017-06-29Labeling · Supplement 6 · standard — Label ↗AP
2015-12-21Labeling · Supplement 5 · standard — Label ↗AP
2015-04-27Manufacturing (CMC) · Supplement 4 · standardAP
2014-09-19Manufacturing (CMC) · Supplement 3 · standardAP
2014-07-28Manufacturing (CMC) · Supplement 2 · standardAP
2014-07-22Manufacturing (CMC) · Supplement 1 · standardAP
2014-03-21Type 1 - New Molecular Entity · Original · standard — 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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