Pharm firm files for FDA approval of oral rosacea drug

September 6, 2005

Newtown, Pa. -- CollaGenex Pharmaceuticals recently filed a New Drug Application (NDA) with the Food and Drug Administration for Oracea, the first orally administered, systemically delivered drug to treat rosacea.

Newtown, Pa. -- CollaGenex Pharmaceuticals recently filed a New Drug Application (NDA) with the Food and Drug Administration for Oracea, the first orally administered, systemically delivered drug to treat rosacea. The NDA included positive outcomes of two clinical trials designed to evaluate the safety and efficacy of Oracea. The trials enrolled a total of 537 patients in 28 centers across the country.

A CollaGenex official said the company was anticipating a 12-month review period, with a projected market launch targeting the third quarter of 2006.

More than 13 million adults in the United States suffer from rosacea.