FDA Accepts New Drug Application for Noven’s Once-Daily MethyPatch

Thursday, December 8th, 2011

NDA for Once-Daily ADHD Patch Accepted by Food and Drug Administration

MIAMI–(BUSINESS WIRE)–Aug. 27, 2002–Noven Pharmaceuticals, Inc. today announced that its New Drug Application (NDA) for once-daily MethyPatch(R) (transdermal methylphenidate system) has been accepted for filing with the U.S. Food and Drug Administration (FDA).

Noven submitted the NDA on June 27, 2002 seeking approval to market MethyPatch for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). Acceptance for filing occurs automatically 60 days after submission of an NDA, unless the FDA indicates during the 60-day period that the application is not sufficiently complete to permit a substantive review.

MethyPatch combines methylphenidate – an established ADHD therapy with Noven’s patented DOT Matrix(TM) patch technology, which is the delivery platform underlying Noven’s Vivelle-Dot(R) and CombiPatch(R) hormone replacement patches. DOT Matrix technology permits Noven to deliver predictable therapeutic doses of a range of prescription therapies through discreet, comfortable and adherent patches that are well suited to active lifestyles.

ADHD is characterized by developmentally inappropriate impulsivity, inattention and hyperactivity. ADHD affects 3% to 5% of school-aged children, and an estimated 1.5 million children are currently on medication to treat this disorder. All presently approved ADHD medications are delivered orally.

About Noven

Noven Pharmaceuticals, Inc., headquartered in Miami, Florida, is a leading developer of advanced transdermal drug delivery technologies and prescription transdermal products.