Daytrana

methylphenidate

Noven Announces Results of Daytrana Advisory Committee Meeting

MIAMI, December 2, 2005 -- Noven Pharmaceuticals, Inc. (NASDAQ:NOVN) announced the results of the Psychopharmacologic Drugs Advisory Committee meeting held earlier today relating to Daytrana (methylphenidate transdermal system).

Daytrana, licensed globally to Shire plc, is an investigational transdermal patch designed for once-daily use to treat attention deficit hyperactivity disorder (ADHD) in children aged 6 to 12 years. An amended New Drug Application (NDA) for Daytrana is currently pending at the U.S. Food and Drug Administration (FDA).

The FDA asked the Advisory Committee to vote on (i) whether the product has been shown to be effective for the treatment of ADHD, and (ii) whether the product has been shown to be acceptably safe in the treatment of ADHD. On the first question, the Committee voted unanimously in favor of the efficacy of the product. On the second question, the Committee voted unanimously in favor of the safety of the product, but recommended that the FDA require post-marketing surveillance and/or studies related to the product. The Advisory Committee also recommended to the FDA that consideration of oral ADHD products be given prior to use of the product, but by a vote of eleven to one rejected a proposal to limit use of the product to patients who cannot use oral methylphenidate products.

"We are pleased that the Committee's vote was supportive of the efficacy and safety of the product," said Robert C. Strauss, Noven's President, CEO & Chairman. "We look forward to the FDA's final decision on the approvability of the amended NDA."

The regulatory review period under the Prescription Drug User Fee Act (PDUFA) for the amended NDA is scheduled to conclude on December 28, 2005. The FDA is not bound by the vote or recommendations of the Advisory Committee.

Source: Noven Pharmaceuticals, Inc.

Related Articles:

Daytrana Approved - Shire plc - Treatment for Attention Deficit Hyperactivity Disorder - April 6, 2006

FDA Declares Daytrana NDA Resubmission to Be Complete Class I Response - March 10, 2006

FDA Issues Approvable Letter for Daytrana Methylphenidate Transdermal System - December 23, 2005

Noven to Commence Manufacture of Daytrana Methylphenidate Transdermal System - December 13, 2005

Developmental Methylphenidate Patch Scheduled for FDA Advisory Committee Review - October 27, 2005

Shire and Noven Resubmitted NDA for MTS, a Candidate Treatment for Pediatric ADHD Patients - July 26, 2005

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