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February 22, 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.
The NDA submission
is supported by results from a multicenter, laboratory classroom study
which evaluated the safety and efficacy of ATS in over 100 pediatric
patients with ADHD.
“The submission of
the ATS NDA for consideration by the FDA represents a significant step
toward our goal of offering a new option for clinicians, caregivers and
patients for the treatment of ADHD. If approved, this investigational
product will provide the first transdermal patch available for the
treatment of ADHD in adults,” said Joel Lippman, M.D., Chief Operating
Officer and Chief Medical Officer, Noven Pharmaceuticals, Inc.
About Noven
Pharmaceuticals, Inc.
Noven
Pharmaceuticals, Inc. is a specialty pharmaceutical company engaged in the
research, development, manufacturing, marketing and sale of prescription
pharmaceutical products. Noven’s mission is to develop and offer
pharmaceutical products that meaningfully benefit patients around the
world, with a commitment to advancing patient care through transdermal drug
delivery. Noven is a stand-alone operating subsidiary of Japan-based
Hisamitsu Pharmaceutical Co., Inc., serving as Hisamitsu’s U.S. platform
for prescription pharmaceuticals, and helping Hisamitsu bring the benefits
of patch therapy to the world. For more information about Noven,
visit http://www.noven.com/. For information about Hisamitsu,
visit https://global.hisamitsu/.
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