Source facts
FDA issued an approval letter for VOQUEZNA TRIPLE PAK on 2026-04-27. The source metadata identifies NDA 215152 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
VOQUEZNA TRIPLE PAK — FDA Approval Letter (NDA 215152)
Issued to PHATHOM. Application is approved as submitted.
Issued
April 27, 2026Application
NDA 505b1 • 215152
Product
VOQUEZNA TRIPLE PAK
Company
PHATHOM
Stage
Final Decision
Assyro regulatory brief
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Key details in this letter
- 1FDA action: approval.
- 2Application: NDA 215152.
- 3Submission: supplement.
- 4Sponsor: PHATHOM.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the VOQUEZNA TRIPLE PAK approval letter
Is VOQUEZNA TRIPLE PAK FDA approved?
This letter documents an FDA approval action: FDA approved NDA 215152 for VOQUEZNA TRIPLE PAK, sponsored by PHATHOM, on April 27, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 215152?
NDA 215152 is the application under which FDA issued this approval letter for VOQUEZNA TRIPLE PAK to PHATHOM. The letter is dated April 27, 2026.
What happens after an FDA approval letter?
The sponsor may market the product in line with the approved labeling. Approval letters typically set post-approval obligations: submitting final content of labeling, meeting any postmarketing requirements or commitments listed in the letter, updating Orange Book patent information within 30 days for NDAs, and ongoing annual reporting under 21 CFR 314.81.