VIIV HLTHCARE — FDA SUPPL Approval for TIVICAY PD (Not disclosed in the FDA record.)

Key facts

What was approved

FDA's record shows VIIV HLTHCARE as the sponsor of TIVICAY PD, with the generic name recorded as unspecified and dosage form TABLET, FOR SUSPENSION. 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 SUPPL (submission number 7) under application number NDA213983, 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 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.

VIIV HLTHCARE’s FDA history

Argus HQ has recorded 2 total FDA actions tied to VIIV HLTHCARE: 0 warning letters, 0 recalls, 2 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

What review priority did FDA assign?

FDA designated this submission as: PRIORITY.

What dosage form is TIVICAY PD?

TIVICAY PD is formulated as: TABLET, FOR SUSPENSION.

What did FDA approve?

FDA's record shows nda approval for TIVICAY PD (unspecified), dosage form TABLET, FOR SUSPENSION, sponsored by VIIV HLTHCARE, under application number NDA213983. 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 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.

Related enforcement actions

• Approval: VIIV HLTHCARE — NDA approval: TIVICAY (unspecified) →