Approval Record: ORZEYFUL — TAKEDA PHARMS USA, ORIG (Not disclosed in the FDA record.)

Key facts

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 TAKEDA PHARMS USA as the sponsor of ORZEYFUL, with the generic name recorded as unspecified and dosage form TABLET. 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 NDA220860, with a submission status date of 20260805. 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.

TAKEDA PHARMS USA’s FDA history

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

Frequently asked questions

Is this product available now?

FDA's record lists a submission status date of 20260805. 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.

Does TAKEDA PHARMS USA have other FDA approval records?

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

What is the FDA application number for this submission?

FDA application number NDA220860, submission 1.

What review priority did FDA assign?

FDA designated this submission as: PRIORITY.

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