JAZZ PHARMS — FDA SUPPL Approval for ZIIHERA (Not disclosed in the FDA record.)

Key facts

What was approved

FDA's record shows JAZZ PHARMS as the sponsor of ZIIHERA, with the generic name recorded as unspecified and dosage form INJECTABLE. A Biologics License Application (BLA) is the FDA pathway used to approve biologic products (such as vaccines, blood products, and cell/gene therapies), requiring evidence of safety, purity, and potency along with manufacturing-process validation specific to biologic manufacturing. This specific application is submission type SUPPL (submission number 2) under application number BLA761416, with a submission status date of 20260825. 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.

Regulatory context

This application was reviewed under FDA's SUPPL submission pathway. A Biologics License Application (BLA) is the FDA pathway used to approve biologic products (such as vaccines, blood products, and cell/gene therapies), requiring evidence of safety, purity, and potency along with manufacturing-process validation specific to biologic manufacturing. 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.

JAZZ PHARMS’s FDA history

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

Frequently asked questions

What dosage form is ZIIHERA?

ZIIHERA is formulated as: INJECTABLE.

What did FDA approve?

FDA's record shows bla approval for ZIIHERA (unspecified), dosage form INJECTABLE, sponsored by JAZZ PHARMS, under application number BLA761416. 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 does the submission type mean?

A Biologics License Application (BLA) is the FDA pathway used to approve biologic products (such as vaccines, blood products, and cell/gene therapies), requiring evidence of safety, purity, and potency along with manufacturing-process validation specific to biologic manufacturing.

Is this product available now?

FDA's record lists a submission status date of 20260825. 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.

Related enforcement actions