PFIZER RECEIVES ZOLOFT OCD INDICATION WITHOUT DOSE-RESPONSE RELATIONSHIP; FIRM HAS SUBMITTED PROPOSED CORRECTIVE PLAN IN RESPONSE TO FDA WARNING LETTER
Executive Summary
Pfizer's fourteen-month wait for final FDA approval for an obsessive-compulsive disorder indication for the antidepressant Zoloft (sertraline) appears in part to be attributable to the company's persistent, but ultimately unsuccessful, pursuit of labeling language to indicate a firm dose-response relationship for the drug.
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