Enforcement Report - Week of March 29, 2023
MIAMI and JERSEY CITY, N.J., Jan. 10, 2023 /PRNewswire/ -- Noven Pharmaceuticals. Inc., (Noven), a wholly owned subsidiary of Hisamitsu Pharmaceutical Co., Inc. focusing on the development of transdermal treatments, announced today that XELSTRYM™ (dextroamphetamine) transdermal system, CII, the first and only FDA-approved amphetamine patch for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in adults and pediatric patients six years and older, will be available across the U.S. for healthcare professionals to prescribe later in the first quarter of 2023.1 In anticipation of this, Noven will be publicly presenting XELSTRYM in a branded capacity for the first time at the American Professional Society of ADHD and Related Disorders (APSARD) Conference being held January 13-15 in Orlando, Florida.
Enforcement Report - Week of December 7, 2022
Enforcement Report - Week of July 6, 2022
Enforcement Report - Week of August 25, 2021
MIAMI & JERSEY CITY, N.J.--(BUSINESS WIRE)--Noven Pharmaceuticals, Inc., (“Noven”) a wholly-owned subsidiary of Hisamitsu Pharmaceutical Co., Inc., today announced it will present the results of a multicenter, phase 2, laboratory classroom study which evaluated the safety and efficacy of its investigational dextroamphetamine transdermal system (“ATS”) in over 100 pediatric patients (ages 6-17 years) with ADHD at the 2021 virtual American Psychiatric Association (APA) Annual Meeting May 1-3, 2021.
Enforcement Report - Week of March 10, 2021
MIAMI & JERSEY CITY, N.J.--(BUSINESS WIRE)--Noven Pharmaceuticals, Inc., (“Noven”) a wholly-owned subsidiary of Hisamitsu Pharmaceutical Co., Inc., today confirmed it has submitted a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market its dextroamphetamine transdermal system (“ATS”). Noven’s ATS, in 4.5mg/9 hours, 9.0 mg/9 hours, 13.5mg/9 hours and 18.0mg/9 hours dosage strengths, is an investigational therapy developed for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) for patients six years and older. Currently, there is no amphetamine-based transdermal treatment option available for ADHD.