GENENTECH — FDA SUPPL Approval for GAZYVA (Not disclosed in the FDA record.)

Key facts

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.

What was approved

FDA's record shows GENENTECH as the sponsor of GAZYVA, 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 43) under application number BLA125486, with a submission status date of 20260925. 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

What is the FDA application number for this submission?

FDA application number BLA125486, submission 43.

What review priority did FDA assign?

FDA designated this submission as: PRIORITY.

What dosage form is GAZYVA?

GAZYVA is formulated as: INJECTABLE.

What did FDA approve?

FDA's record shows bla approval for GAZYVA (unspecified), dosage form INJECTABLE, sponsored by GENENTECH, under application number BLA125486. 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

• Approval (recent): SHANDONG — ANDA approval: SUGAMMADEX SODIUM (unspecified) →
• Approval (recent): PIRAMAL CRITICAL — ANDA approval: DESFLURANE (unspecified) →
• Approval (recent): AUROBINDO PHARMA LTD — ANDA approval: PERAMPANEL (unspecified) →
• Approval (recent): TARO — ANDA approval: LOPERAMIDE HYDROCHLORIDE (unspecified) →
• Approval (recent): LUPIN — ANDA approval: PHYTONADIONE (unspecified) →
• Approval (recent): EVER VALINJECT — NDA approval: Unspecified (unspecified) →
• Approval (recent): GLAND — ANDA approval: LEVOCARNITINE (unspecified) →
• Approval (recent): ABBVIE INC — NDA approval: JUVMO (unspecified) →