Noven Receives Warning Letter

January 17, 2008
Pharmaceutical Technology Editors
ePT--the Electronic Newsletter of Pharmaceutical Technology

Noven Pharmaceuticals received a warning letter from the US Food and Drug Administration stemming from an on-site inspection of the company?s manufacturing facility in Miami, Florida, concluded July 2007.

Miami, FL (Jan. 10)-Noven Pharmaceuticals received a warning letter from the US Food and Drug Administration stemming from an on-site inspection of the company’s manufacturing facility in Miami, Florida, concluded July 2007. At that time, the company’s Form 483 observations related to “difficulties experienced by some patients in removing the release liner of the Daytrana transdermal system.”

Although the warning letter does not restrict production or shipment of the company’s Daytrana product, it does request additional information and analysis related to the cited deficiencies. In particular, the warning letter points to deficiencies related to peel-force specifications for release-liner removal and data supporting the peel-force characteristics of the products “enhanced” release liner through its shelf life.

According to a company announcement, Jeffrey F. Eisenberg, Noven’s interim CEO, said, “We are working very closely with Shire, the global licensee of Daytrana, to promptly respond to the FDA’s letter, and we are committed to working collaboratively with the FDA to fully resolve the issues.”