FDA Approval For Rosacea Treatment Oracea
The Food and Drug Administration approved CollaGenex Pharmaceuticals Inc.'s rosacea treatment Monday.
The drug, called Oracea, is now the first FDA-approved, orally administered drug to treat rosacea.
"Oracea is the first of a series of dermatology products we have in development, and we are very pleased that our (new drug application) was approved by the FDA within 10 months of submission," said Colin Stewart, the company's president and CEO. "Over the past six months, we have built a first-rate specialty sales force to launch Oracea, and all of our representatives were fully trained and in their territories by the end of April. This is an extremely exciting time for CollaGenex, and we look forward to providing dermatologists and their patients with this exciting new therapy to treat rosacea."
Oracea contains doxycycline, the same active ingredient as CollaGenex's gum disease treatment Periostat. The company began focusing on its use in the dermatology market after getting reports from dentists that their patients taking the drug for their gums were surprised to find Periostat was also improving the condition of their skin.
CollaGenex shifted its focus to the dermatology market over the past two years following the approval of generic competition for Periostat.
The drug, called Oracea, is now the first FDA-approved, orally administered drug to treat rosacea.
"Oracea is the first of a series of dermatology products we have in development, and we are very pleased that our (new drug application) was approved by the FDA within 10 months of submission," said Colin Stewart, the company's president and CEO. "Over the past six months, we have built a first-rate specialty sales force to launch Oracea, and all of our representatives were fully trained and in their territories by the end of April. This is an extremely exciting time for CollaGenex, and we look forward to providing dermatologists and their patients with this exciting new therapy to treat rosacea."
Oracea contains doxycycline, the same active ingredient as CollaGenex's gum disease treatment Periostat. The company began focusing on its use in the dermatology market after getting reports from dentists that their patients taking the drug for their gums were surprised to find Periostat was also improving the condition of their skin.
CollaGenex shifted its focus to the dermatology market over the past two years following the approval of generic competition for Periostat.
posted by Madison at 8:15 AM
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