Abbvie Inc

NYSE:ABBV  
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Products, Regulatory

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

Published: 03/17/2021 12:57 GMT
Abbvie Inc (ABBV) - 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.