3/17/2004
From: Associated Press, March 2004
The FDA’s “approval” letter to Seracor, Inc. means that the company will not have to conduct additional clinical or preclinical trials for final approval of the drug Estorra.
Officials for Sepracor said that they will resubmit their new drug application to the FDA and hope to start marketing Estorra as early as the middle of this year.
Related: Nighty Night or Up All Night? An article about sleep and fatigue with AS, featured in the latest issue of Spondyltitis Plus.