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FDA Accepts Amgen's Supplemental New Drug Application For Otezla® For Adults With Mild-To-Moderate Plaque Psoriasis


Amgen today announced that the U.S. Food and Drug Administration has accepted for review the supplemental New Drug Application for Otezla ® for the treatment of adults with mild-to-moderate plaque psoriasis who are candidates for phototherapy or systemic therapy. The FDA has set a Prescription Drug User Fee Act action date of December 19, 2021 . “Otezla has been prescribed to hundreds of thousands of patients with …
– Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) for Otezla ® (apremilast) for the treatment of adults with mild-to-moderate plaque psoriasis who are candidates for phototherapy or systemic therapy. The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of December 19, 2021 . ....

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