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Article: Anesta Corp. Responds to FDA Letter on Actiq News Releases
- Article from:
- PR Newswire
- Article date:
- June 5, 1998
CopyrightCOPYRIGHT 1998 PR Newswire Association LLC. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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SALT LAKE CITY, June 5 /PRNewswire/ -- Anesta Corp. (Nasdaq: NSTA) today announced that the company has responded to a recent letter from the FDA Division of Drug Marketing, Advertising and Communications (DDMAC) concerning certain statements made by Anesta in news releases reporting on the clinical assessment of the efficacy and safety of Actiq (oral transmucosal fentanyl citrate) in the treatment of breakthrough pain.
The releases cited by DDMAC were issued by Anesta on July 25, 1996, and May 20 and August 18, 1997. The July 25, 1996, news release announced the completion of enrollment in the Actiq Phase 3 clinical trials; the May 20, 1997, news release ...