← FDA DRUG APPROVALS

FDA NDA · NDA215358

SCEMBLIX

asciminib

Sponsor: NOVARTIS

APPLICATION
NDA215358
TYPE
NDA
ORIGINAL APPROVAL
2021-10-29
LATEST ACTION
2025-11-25
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

SCEMBLIX · ReferencePrescription
ASCIMINIB HYDROCHLORIDE EQ 40MG BASE · TABLET · ORAL
SCEMBLIX · ReferencePrescription
ASCIMINIB HYDROCHLORIDE EQ 100MG BASE · TABLET · ORAL
SCEMBLIX · ReferencePrescription
ASCIMINIB HYDROCHLORIDE EQ 20MG BASE · TABLET · ORAL

Approval history

2025-11-25Efficacy · Supplement 12 · standard — Letter ↗AP
2025-10-02Efficacy · Supplement 10 · standard — Label ↗AP
2024-10-29Efficacy · Supplement 8 · priority — Label ↗AP
2024-10-29Efficacy · Supplement 9 · priority — Letter ↗AP
2024-08-07Efficacy · Supplement 7 · standard — Label ↗AP
2024-06-18Manufacturing (CMC) · Supplement 5 · standardAP
2023-11-08Labeling · Supplement 4 · standard — Label ↗AP
2023-06-26Labeling · Supplement 3 · standard — Label ↗AP
2022-10-12Efficacy · Supplement 1 · priority — Letter ↗AP
2021-10-29Type 1 - New Molecular Entity · Original · priority — Label ↗AP
2021-10-29Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →