OUTLOOK THERAPEUTICS, INC. — FDA ORIG Approval for LYTENAVA (Not disclosed in the FDA record.)

Key facts

Regulatory context

This application was reviewed under FDA's ORIG 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 OUTLOOK THERAPEUTICS, INC. as the sponsor of LYTENAVA, with the generic name recorded as unspecified and dosage form VIAL. 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 ORIG (submission number 1) under application number BLA761320, with a submission status date of 20260724. 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.

OUTLOOK THERAPEUTICS, INC.’s FDA history

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

Frequently asked questions

Is this product available now?

FDA's record lists a submission status date of 20260724. 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.

Does OUTLOOK THERAPEUTICS, INC. have other FDA approval records?

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

What is the FDA application number for this submission?

FDA application number BLA761320, submission 1.

What review priority did FDA assign?

FDA designated this submission as: STANDARD.

Related enforcement actions