ExtinaTreatment for Seborrheic Dermatitis
Update: Extina (ketoconazole) Foam Now FDA Approved - June 12, 2007
Connetics' New Drug Application for Extina Has Been Accepted for Filing by the FDA
PALO ALTO, Calif., April 08, 2004 -- Connetics Corporation , a specialty pharmaceutical company focused on dermatology, today announced that it has received confirmation that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company's New Drug Application (NDA) for Extina, as of January 26, 2004 with a user fee goal date of September 24, 2004.
Extina is an investigational new drug formulation of 2% ketoconazole delivered in the Company's proprietary VersaFoam delivery system, as a potential new treatment for seborrheic dermatitis.
Connetics Corporation is a specialty pharmaceutical company focused on the development and commercialization of innovative therapeutics for the dermatology market. The Company's marketed products are OLUX (clobetasol propionate) Foam, 0.05%, Luxiq (betamethasone valerate) Foam, 0.12%, and Soriatane (acitretin) capsules, 10 mg and 25 mg. Connetics is developing Extina, a foam formulation of the antifungal drug ketoconazole, Actiza, a foam formulation of clindamycin for treating acne, and Velac, a combination of clindamycin and tretinoin for treating acne. Connetics has branded its innovative foam drug delivery vehicle VersaFoam. These formulations aim to improve the management of dermatological diseases and provide significant product differentiation, and have earned wide acceptance by both physicians and patients due to their clinical effectiveness, high quality and cosmetic elegance. For more information about Connetics and its products, please visit www.connetics.com
Posted: April 2004
- FDA Approves Extina for the Treatment of Seborrheic Dermatitis - June 13, 2007
- Connetics Receives FDA Non-Approvable Letter for Extina - November 24, 2004