SPY416.07+3.90 0.95%
DIA341.30+3.18 0.94%
IXIC13,950.22+163.95 1.19%

BRIEF-Abbvie Announces Extension Of Review For Supplemental New Drug Application Of Upadacitinib For Treatment Of Adults With Active Psoriatic Arthritis

· 03/17/2021 08:50
BRIEF-Abbvie Announces Extension Of Review For Supplemental New Drug Application Of Upadacitinib For Treatment Of Adults With Active Psoriatic Arthritis

- Abbvie Inc ABBV.N:

  • ABBVIE ANNOUNCES EXTENSION OF REVIEW FOR SUPPLEMENTAL NEW DRUG APPLICATION OF UPADACITINIB FOR TREATMENT OF ADULTS WITH ACTIVE PSORIATIC ARTHRITIS

  • ABBVIE INC - UPDATED PRESCRIPTION DRUG USER FEE ACT ACTION DATE HAS BEEN EXTENDED THREE MONTHS TO LATE Q2 2021

  • ABBVIE - RECENTLY RECEIVED AN INFORMATION REQUEST FROM FDA FOR AN UPDATED ASSESSMENT OF BENEFIT-RISK PROFILE FOR UPADACITINIB IN PSORIATIC ARTHRITIS

  • ABBVIE INC - CO RESPONDED TO REQUEST AND FDA WILL REQUIRE ADDITIONAL TIME FOR A FULL REVIEW OF SUBMISSION

  • ABBVIE INC - SEPARATELY, RECEIVED A SIMILAR REQUEST FROM FDA RELATED TO SNDA FOR UPADACITINIB IN ATOPIC DERMATITIS

Source text for Eikon: ID:nPn41lQT7a

Further company coverage: ABBV.N


((Reuters.Briefs@thomsonreuters.com;))