Acquisition of Marketing Approval for VYVANSE Capsule 20mg/30mg for Treatment of Attention Deficit Hyperactivity Disorder

Osaka, Japan, April 12, 2019 - Shionogi & Co., Ltd. (Head Office: Osaka; President & CEO: Isao Teshirogi, Ph.D.; hereafter “Shionogi”) announced that that Shionogi received marketing approval for VYVANSE® (lisdexamfetamine dimesylate) from the Ministry of Health, Labour and Welfare on March 26, 2019. The product is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in children.
VYVANSE® is a once-daily drug that stimulates the release and blocks the reuptake of dopaminenoradrenaline. VYVANSE® is a prodrug-typed product intending to maintain the blood level of a pharmacologically active drug. The prodrug technology contribute its slow conversion in the body into an active drug and inhibit rapid elevation of the blood level.
Because the substance contained in this product is designated as a stimulant drug substance, the product is approved for marketing on the condition that necessary measures are taken, such as prescription by medical experts well-versed in diagnosis/treatment of ADHD which should be given only to appropriate patients, and handling only by medical institutions and pharmacies, where the risks of this drug including dependence can be fully controlled.
Shionogi will establish a strict distribution management system based on the approval conditions and make a positive contribution to therapy for patients who need VYVANSE®.

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