MIMRYLO (TAKEDA PHARMACEUTICALS U.S.A., INC.): FDA ORIG Approval, 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 PHARMACEUTICALS U.S.A., INC. as the sponsor of MIMRYLO, with the generic name recorded as unspecified and dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION. 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 NDA220605, with a submission status date of 20260828. 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 PHARMACEUTICALS U.S.A., INC.’s FDA history

Argus HQ has recorded 1 total FDA action tied to TAKEDA PHARMACEUTICALS U.S.A., INC.: 0 warning letters, 0 recalls, 1 approval record, and 0 Form 483 inspection citations.

Frequently asked questions

What is the FDA application number for this submission?

FDA application number NDA220605, submission 1.

What review priority did FDA assign?

FDA designated this submission as: PRIORITY.

What dosage form is MIMRYLO?

MIMRYLO is formulated as: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION.

What did FDA approve?

FDA's record shows nda approval for MIMRYLO (unspecified), dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION, sponsored by TAKEDA PHARMACEUTICALS U.S.A., INC., under application number NDA220605. 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.

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