Post Traumatic Stress Disorder Trials Should Use Fixed Dose, Committee Says
Sponsors seeking a post traumatic stress disorder indication should conduct fixed-dose studies, FDA's Psychopharmacologic Drugs Advisory Committee advised during its Oct. 8 review of Pfizer's Zoloft.
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Additional trials of Pfizer's Zoloft (sertraline) in post-traumatic stress disorder should focus on the drug's treatment benefit in men, FDA's Psychopharmacologic Drugs Advisory Committee said Oct. 8. The committee recommended approval of the product for PTSD.
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