FDA letter monthly archive

FDA Letters in October 2026

Name: FDA Letters in October 2026
Creator: Assyro AI
License: https://www.usa.gov/government-works

Browse FDA application-action, complete response, and warning letters issued or posted in October 2026. Each result links to a structured letter page with source-document access, metadata, and regulatory intelligence summaries.

ALApproval Letter
Approval Letter GENENTECH INC (Oct 5, 2026)
FDA posted an approval letter for ROZLYTREK on 2026-10-05. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 212725, NDA 218550 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAOct 5, 2026
US FDA• ROZLYTREK
ALApproval Letter
Approval Letter EVER VALINJECT (Oct 5, 2026)
FDA posted an approval letter for NDA 219617 on 2026-10-05. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 219617 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAOct 5, 2026
US FDA• NDA 219617
ALApproval Letter
Approval Letter AGL WELDING SUPPLY CO INC DBA AGL GAS TECHNOLOGIES (Oct 2, 2026)
FDA posted an approval letter for CARBON DIOXIDE, USP on 2026-10-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 222000 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAOct 2, 2026
US FDA• CARBON DIOXIDE, USP
ALApproval Letter
Approval Letter MSD MERCK CO (Oct 1, 2026)
FDA posted an approval letter for PIFELTRO on 2026-10-01. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 210806 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAOct 1, 2026
US FDA• PIFELTRO
ALApproval Letter
Approval Letter BRISTOL (Oct 1, 2026)
FDA posted an approval letter for CAMZYOS on 2026-10-01. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 214998 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAOct 1, 2026
US FDA• CAMZYOS
ALApproval Letter
Approval Letter B BRAUN (Oct 1, 2026)
FDA posted an approval letter for DEXTROSE 2.5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER, DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE 2.5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER on 2026-10-01. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 019631 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAOct 1, 2026
US FDA• DEXTROSE 2.5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER / DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER / DEXTROSE 2.5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
ALApproval Letter
Approval Letter JAZZ (Oct 1, 2026)
FDA posted an approval letter for ZEPZELCA on 2026-10-01. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 213702 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAOct 1, 2026
US FDA• ZEPZELCA
ALApproval Letter
Approval Letter CHEPLAPHARM (Oct 1, 2026)
FDA posted an approval letter for XENICAL on 2026-10-01. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 020766 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAOct 1, 2026
US FDA• XENICAL
ALApproval Letter
Approval Letter CELLTRION INC (Oct 1, 2026)
FDA posted an approval letter for AVTOZMA on 2026-10-01. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761420 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAOct 1, 2026
US FDA• AVTOZMA
ALApproval Letter
Approval Letter MSD MERCK CO (Oct 1, 2026)
FDA posted an approval letter for DELSTRIGO on 2026-10-01. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 210807 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAOct 1, 2026
US FDA• DELSTRIGO
ALApproval Letter
Approval Letter CELLTRION INC (Oct 1, 2026)
FDA posted an approval letter for EYDENZELT on 2026-10-01. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761377 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAOct 1, 2026
US FDA• EYDENZELT
WLWarning Letter
Warning Letter The Platinum Healthcare LLC (Oct 1, 2026)
FDA issued a warning letter to The Platinum Healthcare LLC concerning Unapproved New Drugs. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedOct 1, 2026
US FDA• Unapproved New Drugs
WLWarning Letter
Warning Letter Bioactive Services USA, LLC / Herstat Inc. (Oct 1, 2026)
FDA issued a warning letter to Bioactive Services USA, LLC / Herstat Inc. concerning Unapproved New Drugs. Deterministic full-text screening identifies discussion of Unapproved products and premarket authorization, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedOct 1, 2026
US FDA• Unapproved New Drugs
WLWarning Letter
Warning Letter DesBio/Deseret Biologicals, Inc. (Oct 1, 2026)
FDA issued a warning letter to DesBio/Deseret Biologicals, Inc. concerning Unapproved New Drugs. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedOct 1, 2026
US FDA• Unapproved New Drugs
WLWarning Letter
Warning Letter Amazon.com, Inc. (Oct 1, 2026)
FDA issued a warning letter to Amazon.com, Inc. concerning Unapproved New Drugs. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedOct 1, 2026
US FDA• Unapproved New Drugs
WLWarning Letter
Warning Letter OrganiCare, LLC / OrganiCare Nature’s Science, LLC (Oct 1, 2026)
FDA issued a warning letter to OrganiCare, LLC / OrganiCare Nature’s Science, LLC concerning Unapproved New Drugs. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedOct 1, 2026
US FDA• Unapproved New Drugs
WLWarning Letter
Warning Letter Walmart, Inc. (Oct 1, 2026)
FDA issued a warning letter to Walmart, Inc. concerning Unapproved New Drugs. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedOct 1, 2026
US FDA• Unapproved New Drugs
WLWarning Letter
Warning Letter Aidance Scientific, Inc. (Oct 1, 2026)
FDA issued a warning letter to Aidance Scientific, Inc. concerning Unapproved New Drugs. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedOct 1, 2026
US FDA• Unapproved New Drugs
WLWarning Letter
Warning Letter Graceful Touch, LLC (Oct 1, 2026)
FDA issued a warning letter to Graceful Touch, LLC concerning Unapproved New Drugs. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedOct 1, 2026
US FDA• Unapproved New Drugs
WLWarning Letter
Warning Letter RoyceDerm LLC (Oct 1, 2026)
FDA issued a warning letter to RoyceDerm LLC concerning Unapproved New Drugs. Deterministic full-text screening identifies discussion of Unapproved products and premarket authorization, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedOct 1, 2026
US FDA• Unapproved New Drugs
WLWarning Letter
Warning Letter Terramed (Oct 1, 2026)
FDA issued a warning letter to Terramed concerning Unapproved New Drugs. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedOct 1, 2026
US FDA• Unapproved New Drugs

Approval Letter GENENTECH INC (Oct 5, 2026)

Approval Letter EVER VALINJECT (Oct 5, 2026)

Approval Letter AGL WELDING SUPPLY CO INC DBA AGL GAS TECHNOLOGIES (Oct 2, 2026)

Approval Letter MSD MERCK CO (Oct 1, 2026)

Approval Letter BRISTOL (Oct 1, 2026)

Approval Letter B BRAUN (Oct 1, 2026)

Approval Letter JAZZ (Oct 1, 2026)

Approval Letter CHEPLAPHARM (Oct 1, 2026)

Approval Letter CELLTRION INC (Oct 1, 2026)

Approval Letter MSD MERCK CO (Oct 1, 2026)

Approval Letter CELLTRION INC (Oct 1, 2026)

Warning Letter The Platinum Healthcare LLC (Oct 1, 2026)

Warning Letter Bioactive Services USA, LLC / Herstat Inc. (Oct 1, 2026)

Warning Letter DesBio/Deseret Biologicals, Inc. (Oct 1, 2026)

Warning Letter Amazon.com, Inc. (Oct 1, 2026)

Warning Letter OrganiCare, LLC / OrganiCare Nature’s Science, LLC (Oct 1, 2026)

Warning Letter Walmart, Inc. (Oct 1, 2026)

Warning Letter Aidance Scientific, Inc. (Oct 1, 2026)

Warning Letter Graceful Touch, LLC (Oct 1, 2026)

Warning Letter RoyceDerm LLC (Oct 1, 2026)

Warning Letter Terramed (Oct 1, 2026)