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Dupixent

BLA 761055, held by Regeneron Pharmaceuticals. Dupilumab.

  • First approved: Mar 28, 2017
  • Review: Priority
  • Supplements approved: 32
  • Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 33 submissions below
DateSubmissionStatusDocuments
Apr 22, 2026Supplement 74Efficacy (new indication or use) · Standard reviewApprovedLetterLabel
Feb 23, 2026Supplement 75Efficacy (new indication or use) · Priority reviewApprovedLabelLetter
Jun 18, 2025Supplement 70Efficacy (new indication or use) · Priority reviewApprovedLabelLetter
Apr 17, 2025Supplement 51Efficacy (new indication or use) · Standard reviewApprovedLetterLabel
Sep 27, 2024Supplement 64Efficacy (new indication or use) · Priority reviewApprovedLabelLetter
Sep 12, 2024Supplement 66Efficacy (new indication or use) · Priority reviewApprovedLabelLetter
Jan 25, 2024Supplement 57Efficacy (new indication or use) · Priority reviewApprovedLabelLetter
Jan 12, 2024Supplement 55Efficacy (new indication or use) · Standard reviewApprovedLabelLetter
Sep 28, 2022Supplement 44Efficacy (new indication or use) · Priority reviewApprovedLabelLetter
Jun 7, 2022Supplement 42Efficacy (new indication or use) · Priority reviewApprovedLetterLabel
May 20, 2022Supplement 40Efficacy (new indication or use) · Priority reviewApprovedReviewLabelLetter
Oct 20, 2021Supplement 31Efficacy (new indication or use) · Standard reviewApprovedLabelLetter
Jun 14, 2021Supplement 16Efficacy (new indication or use) · Standard reviewApprovedLetterLabel
Jun 18, 2020Supplement 17Efficacy (new indication or use) · Standard reviewApprovedReviewLabelLetter
May 26, 2020Supplement 20Efficacy (new indication or use) · Priority reviewApprovedLetterLabel
Jun 26, 2019Supplement 14Efficacy (new indication or use) · Priority reviewApprovedReviewLetterLabel
Mar 11, 2019Supplement 12Efficacy (new indication or use) · Priority reviewApprovedReviewLetterLabel
Oct 19, 2018Supplement 7Efficacy (new indication or use) · Standard reviewApprovedReviewLetterLabel
Apr 10, 2018Supplement 3Efficacy (new indication or use) · Standard reviewApprovedLetterLabel
Mar 28, 2017Original applicationNew molecular entity · Priority reviewApprovedReviewLetterLabel

Products

1 strengths and forms
ProductActive ingredientMarketing
Dupixent150MG/ML · injectable; injectionDupilumabRx
All 33 submissions, including labeling and manufacturing supplements
DateSubmissionStatusDocuments
Jul 15, 2026Supplement 76Labeling · Standard reviewApprovedLetterLabel
Apr 22, 2026Supplement 74Efficacy (new indication or use) · Standard reviewApprovedLetterLabel
Apr 16, 2026Supplement 82Labeling · Standard reviewApprovedLabelLetter
Feb 23, 2026Supplement 75Efficacy (new indication or use) · Priority reviewApprovedLabelLetter
Jun 18, 2025Supplement 70Efficacy (new indication or use) · Priority reviewApprovedLabelLetter
Apr 17, 2025Supplement 51Efficacy (new indication or use) · Standard reviewApprovedLetterLabel
Apr 16, 2025Supplement 72Labeling · Standard reviewApprovedLetterLabel
Sep 27, 2024Supplement 64Efficacy (new indication or use) · Priority reviewApprovedLabelLetter
Sep 12, 2024Supplement 66Efficacy (new indication or use) · Priority reviewApprovedLabelLetter
Apr 12, 2024Supplement 59Labeling · Standard reviewApprovedLabelLetter
Jan 25, 2024Supplement 57Efficacy (new indication or use) · Priority reviewApprovedLabelLetter
Jan 12, 2024Supplement 55Efficacy (new indication or use) · Standard reviewApprovedLabelLetter
Sep 29, 2023Supplement 54Labeling · Standard reviewApprovedLetterLabel
Jul 14, 2023Supplement 50Labeling · Standard reviewApprovedLabelLetter
Oct 17, 2022Supplement 46Labeling · Standard reviewApprovedLabel
Sep 28, 2022Supplement 44Efficacy (new indication or use) · Priority reviewApprovedLabelLetter
Jun 7, 2022Supplement 42Efficacy (new indication or use) · Priority reviewApprovedLetterLabel
May 20, 2022Supplement 40Efficacy (new indication or use) · Priority reviewApprovedReviewLabelLetter
Dec 22, 2021Supplement 33Labeling · Standard reviewApprovedLetterLabel
Dec 22, 2021Supplement 27Labeling · Standard reviewApprovedLetterLabel
Dec 22, 2021Supplement 21Labeling · Standard reviewApprovedLetterLabel
Oct 20, 2021Supplement 31Efficacy (new indication or use) · Standard reviewApprovedLabelLetter
Oct 1, 2021Supplement 35Labeling · Standard reviewApprovedLetterLabel
Jun 14, 2021Supplement 16Efficacy (new indication or use) · Standard reviewApprovedLetterLabel
Jun 18, 2020Supplement 17Efficacy (new indication or use) · Standard reviewApprovedReviewLabelLetter
Jun 18, 2020Supplement 15Labeling · Standard reviewApprovedLabelLetter
May 26, 2020Supplement 20Efficacy (new indication or use) · Priority reviewApprovedLetterLabel
Jun 26, 2019Supplement 14Efficacy (new indication or use) · Priority reviewApprovedReviewLetterLabel
Mar 11, 2019Supplement 12Efficacy (new indication or use) · Priority reviewApprovedReviewLetterLabel
Oct 19, 2018Supplement 7Efficacy (new indication or use) · Standard reviewApprovedReviewLetterLabel
Apr 10, 2018Supplement 3Efficacy (new indication or use) · Standard reviewApprovedLetterLabel
Jan 10, 2018Supplement 5Labeling · Standard reviewApprovedLabelLetter
Mar 28, 2017Original applicationNew molecular entity · Priority reviewApprovedReviewLetterLabel

Identifiers

Application
BLA 761055

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters

Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.