FDA Approves APREPITANT — ORIG Submission by AZURITY, Not disclosed in the FDA record.

Key facts

Regulatory context

This application was reviewed under FDA's standard review pathway, which typically targets a 10-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. FDA publishes approval and submission records so physicians, competitors, and investors can track which sponsors and products have cleared a given regulatory pathway.

What was approved

FDA's record shows AZURITY as the sponsor of APREPITANT, with the generic name recorded as Not disclosed in the FDA record. and dosage form EMULSION. 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 ORIG (submission number 1) under application number NDA218754, with a submission status date of 20260616. 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.

AZURITY’s FDA history

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

Frequently asked questions

What dosage form is APREPITANT?

APREPITANT is formulated as: EMULSION.

What did FDA approve?

FDA's record shows NDA approval for APREPITANT (Not disclosed in the FDA record.), dosage form EMULSION, sponsored by AZURITY, under application number NDA218754. FDA publishes approval and submission records so physicians, competitors, and investors can track which sponsors and products have cleared a given regulatory pathway.

What does the submission type mean?

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.

Is this product available now?

FDA's record lists a submission status date of 20260616. 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.

Related enforcement actions