IONIS PHARMS INC — FDA SUPPL Approval for TRYNGOLZA (AUTOINJECTOR) (Not disclosed in the FDA record.)

Key facts

Regulatory context

This application was reviewed under FDA's priority review pathway, granted when a product may offer a significant improvement over existing treatments, which typically targets a 6-month review goal measured from submission. A New Drug Application (NDA) is the FDA pathway used to approve a brand-name drug for the first time. An NDA requires the sponsor to submit the full preclinical and clinical trial data package demonstrating the product's safety and effectiveness for its proposed 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.

What was approved

FDA's record shows IONIS PHARMS INC as the sponsor of TRYNGOLZA (AUTOINJECTOR), with the generic name recorded as Not disclosed in the FDA record. and dosage form SOLUTION. A New Drug Application (NDA) is the FDA pathway used to approve a brand-name drug for the first time. An NDA requires the sponsor to submit the full preclinical and clinical trial data package demonstrating the product's safety and effectiveness for its proposed use, along with manufacturing and labeling information. This specific application is submission type SUPPL (submission number 4) under application number NDA218614, with a submission status date of 20260624. 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.

IONIS PHARMS INC’s FDA history

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

Frequently asked questions

Does IONIS PHARMS INC have other FDA approval records?

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

What is the FDA application number for this submission?

FDA application number NDA218614, submission 4.

What review priority did FDA assign?

FDA designated this submission as: PRIORITY.

What dosage form is TRYNGOLZA (AUTOINJECTOR)?

TRYNGOLZA (AUTOINJECTOR) is formulated as: SOLUTION.

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