Key facts
| Sponsor | BRISTOL MYERS SQUIBB |
|---|---|
| Brand name | ZENBEXUS |
| Generic name | unspecified |
| Dosage form | CAPSULE |
| Application number | NDA221075 |
| Submission number | 1 |
| Submission type | ORIG |
| Review priority | PRIORITY |
| Status date | Not disclosed in the FDA record. |
Regulatory context
This application was reviewed under FDA's ORIG submission pathway. A New Drug Application (NDA) is the FDA pathway used to approve a new drug product, typically requiring the sponsor to submit full preclinical and clinical evidence of safety and efficacy for the intended 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. 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. 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.
What was approved
FDA's record shows BRISTOL MYERS SQUIBB as the sponsor of ZENBEXUS, with the generic name recorded as unspecified and dosage form CAPSULE. A New Drug Application (NDA) is the FDA pathway used to approve a new drug product, typically requiring the sponsor to submit full preclinical and clinical evidence of safety and efficacy for the intended use, along with manufacturing and labeling information. This specific application is submission type ORIG (submission number 1) under application number NDA221075, with a submission status date of 20260813. 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. 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. 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.
Frequently asked questions
- Is this product available now?
- FDA's record lists a submission status date of 20260813. 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. 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.
- What is the FDA application number for this submission?
- FDA application number NDA221075, submission 1.
- What review priority did FDA assign?
- FDA designated this submission as: PRIORITY.
- What dosage form is ZENBEXUS?
- ZENBEXUS is formulated as: CAPSULE.
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Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). FDA ORIG Approval: ZENBEXUS — BRISTOL MYERS SQUIBB (Not disclosed in the FDA record.). Digital Empire Holdings LLC. Retrieved from https://argushq.ai/approval/bristol-myers-squibb-nda221075-2026-08-13
"FDA ORIG Approval: ZENBEXUS — BRISTOL MYERS SQUIBB (Not disclosed in the FDA record.)." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/approval/bristol-myers-squibb-nda221075-2026-08-13.
Argus HQ Research. "FDA ORIG Approval: ZENBEXUS — BRISTOL MYERS SQUIBB (Not disclosed in the FDA record.)." Digital Empire Holdings LLC. Accessed August 27, 2026. https://argushq.ai/approval/bristol-myers-squibb-nda221075-2026-08-13.
@misc{argushq_argushq_ai_approval_bristol_myers_squibb_nda221075_2026_08_13_2026,
title = {FDA ORIG Approval: ZENBEXUS — BRISTOL MYERS SQUIBB (Not disclosed in the FDA record.)},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire Holdings LLC},
url = {https://argushq.ai/approval/bristol-myers-squibb-nda221075-2026-08-13},
note = {Accessed: August 27, 2026}
}Source: FDA.gov — Approvals ↗