MIAMI--(BUSINESS WIRE)--Jan 10, 2008 - Noven Pharmaceuticals, Inc. (NASDAQ:NOVN) announced that yesterday it received a warning letter from the U.S. Food and Drug Administration (FDA) related to a prior on-site inspection of Noven's Miami manufacturing facility.
The FDA inspection concluded in early July 2007 and, as disclosed at that time by Noven, resulted in FDA observations on Form 483. The majority of the observations on Form 483 related to difficulties experienced by some patients in removing the release liner of the Daytrana(TM) transdermal system. Noven submitted a response to the FDA's observations in July 2007.
In the warning letter, the FDA cites Current Good Manufacturing Practice deficiencies related to (i) peel force specifications for removal of Daytrana's release liner, and (ii) data supporting the peel force characteristics of Daytrana's enhanced release liner throughout the product's shelf life. The warning letter does not restrict production or shipment of Daytrana(TM) product; it does request additional information and analysis related to the cited deficiencies, instructs Noven to take prompt action to address the FDA's concerns, and states that failure to do so may result in further regulatory action.
"Compliance with FDA regulations is taken very seriously at Noven, and this matter is receiving the highest priority within the company," said Jeffrey F. Eisenberg, Noven's Interim Chief Executive Officer. "We are working very closely with Shire, the global licensee of Daytrana(TM), to promptly respond to the FDA's letter, and we are committed to working collaboratively with the FDA to fully resolve the issues."
The warning letter will be posted on the FDA's website at www.fda.gov and, once posted, will be available for viewing.
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