DUSA Announces Nicomide(R) No Longer To Be Marketed As A Prescription Product

July 18, 2008 9:06 AM EDT

DUSA Pharmaceuticals (NASDAQ: DUSA) reported that Nicomide(R), a vitamin-mineral product currently prescribed by dermatologists, will no longer be manufactured and marketed as a prescription product. The decision comes as a proactive action in response to discussions with the Food and Drug Administration (FDA).

DUSA has placed a voluntary hold on existing inventory of Nicomide under its control pending an upcoming meeting with the FDA. The disposition of this inventory will be determined by the outcome of the meeting. In parallel, repackaging efforts are underway to re-label additional inventory with DSHEA (Dietary Supplement Health and Education Act) compliant labeling.

"After reviewing various options, this commercial strategy, in light of the current regulatory environment, will allow DUSA to explore new marketing channels, product categories (DSHEA) and the possible sale or licensing of the product in order to meet strong product demand while DUSA complies with FDA policy guidelines," said Bob Doman, President and CEO of DUSA. "The company's focus has and will be to maximize revenue across its entire product portfolio which includes Levulan(R) Photodynamic Therapy (PDT) and to continue to explore new strategic opportunities that will position DUSA as a leader in the dermatology community."

DUSA Pharmaceuticals, Inc. is an integrated dermatology pharmaceutical company focused primarily on the development and marketing of its Levulan(R) Photodynamic Therapy (PDT) technology platform, and complementary dermatology products.

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