Pfizer gets FDA approval for Zoloft
Pfizer has received US Food and Drug Administration approval for thelong-term use of its selective serotonin reuptake inhibitor antidepressant Zoloft (sertraline HCl) in patients with post-traumatic stress disorder.
The FDA based its decision on a study which demonstrated that patients suffering from PTSD who had previously responded during a 24-week trial of Zoloft therapy maintained a response for the following 28-week period over three core system clusters; re-experiencing/intrusion, avoidance/numbing and arousal.
Zoloft is currently the only medication approved for the treatment of PTSD in the USA (Marketletter December 13, 1999) and is also the most prescribed drug in that country for mood and anxiety disorders, according to Pfizer.
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