Friday, July 18, 2008

DUSA pulls dermatologist product for FDA approval

By Mass High Tech Staff

DUSA Pharmaceuticals Inc. has announced it will voluntariliy hold manufacturing and marketing of its vitamin-mineral product used by dermatologists,  Nicomide, pending U.S. Food and Drug Administration approval, according to officials.

When the Wilmington-based company bought Sirius Laboratories Inc. in early 2006 for $30 million , it also acquired Sirius’ Nicomide, which had not received FDA approved registration. With the FDA buckling down on marketed products without FDA registration, DUSA said it plans to hold its marketing decisions of the product until an outcome of the FDA registration has been reached.

DUSA Pharmaceuticals (Nasdaq:DUSA) is a biopharmaceutical company primarily focused on the development and marketing of Levulan Photodynamic Therapy (PDT) for multiple medical indications, with its primary focus on dermatology. PDT uses light-activated compounds such as Levulan to induce a therapeutic or detection effect.

In 2007, DUSA reported a net loss of $14.8 million on $27.7 million in total revenue.