FDA ORIG Approval: UTEBZI — GLAXOSMITHKLINE (Not disclosed in the FDA record.)

Key facts

Regulatory context

This application was reviewed under FDA's priority review pathway, granted when a product may offer a significant improvement over existing treatments, which typically targets a 6-month review goal measured from submission. A New Drug Application (NDA) is the FDA pathway used to approve a brand-name drug for the first time. An NDA requires the sponsor to submit the full preclinical and clinical trial data package demonstrating the product's safety and effectiveness for its proposed use, along with manufacturing and labeling information. FDA approval of an application does not itself guarantee ongoing marketing; sponsors remain subject to post-approval manufacturing inspections and adverse-event reporting requirements.

What was approved

FDA's record shows GLAXOSMITHKLINE as the sponsor of UTEBZI, with the generic name recorded as Not disclosed in the FDA record. and dosage form TABLET. A New Drug Application (NDA) is the FDA pathway used to approve a brand-name drug for the first time. An NDA requires the sponsor to submit the full preclinical and clinical trial data package demonstrating the product's safety and effectiveness for its proposed use, along with manufacturing and labeling information. This specific application is submission type ORIG (submission number 1) under application number NDA215960, with a submission status date of 20260617. FDA publishes approval and submission records so physicians, competitors, and investors can track which sponsors and products have cleared a given regulatory pathway. An approval reflects FDA's determination on the application as submitted; any post-approval changes to manufacturing, labeling, or use typically require a separate supplemental submission. This record is drawn directly from FDA's own approvals database rather than from company press materials. FDA publishes approval and submission records so physicians, competitors, and investors can track which sponsors and products have cleared a given regulatory pathway. An approval reflects FDA's determination on the application as submitted; any post-approval changes to manufacturing, labeling, or use typically require a separate supplemental submission.

GLAXOSMITHKLINE’s FDA history

Argus HQ has recorded 1 total FDA action tied to GLAXOSMITHKLINE: 0 warning letters, 0 recalls, 1 approval record, and 0 Form 483 inspection citations.

Frequently asked questions

What did FDA approve?

FDA's record shows NDA approval for UTEBZI (Not disclosed in the FDA record.), dosage form TABLET, sponsored by GLAXOSMITHKLINE, under application number NDA215960. FDA publishes approval and submission records so physicians, competitors, and investors can track which sponsors and products have cleared a given regulatory pathway.

What does the submission type mean?

A New Drug Application (NDA) is the FDA pathway used to approve a brand-name drug for the first time. An NDA requires the sponsor to submit the full preclinical and clinical trial data package demonstrating the product's safety and effectiveness for its proposed use, along with manufacturing and labeling information.

Is this product available now?

FDA's record lists a submission status date of 20260617. Availability, pricing, and distribution details beyond the submission status date are Not disclosed in the FDA record. FDA publishes approval and submission records so physicians, competitors, and investors can track which sponsors and products have cleared a given regulatory pathway.

Does GLAXOSMITHKLINE have other FDA approval records?

This is the only FDA action Argus HQ has on file for GLAXOSMITHKLINE so far. Argus ingests new FDA records daily.

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