First Oral Rosacea Drug Receives FDA Approval
CollaGenex said Tuesday it has received U.S. approval to market Oracea, which the company said is the first approved oral rosacea drug.
The company said the Food and Drug Administration has cleared for market Oracea to treat adults with the inflammatory lesions, including papules and pustules, caused by the skin condition.
CollaGenex said it would roll out the new dermatologic drug in July.
"Oracea is the first FDA-approved, orally-administered, systemically-delivered drug to treat rosacea," the company said in a statement.
Rosacea affects about 14 million adults in the United States, CollaGenex said.
"Oracea is the first of a series of dermatology products we have in development, and we are very pleased that our NDA was approved by the FDA within 10 months of submission," said Colin Stewart, CollaGenex's president and chief executive officer.
<< Home