Pediatric Prozac clears FDA
Executive Summary
FDA clears Lilly's Prozac (fluoxetine) for treatment of major depressive disorder and obsessive compulsive disorder in children seven to 17 Jan. 3. The company received additional market exclusivity from February 2001 until August 2001 for conducting the pediatric trials. As a Phase IV postmarketing commitment, Lilly will "evaluate any potential impact of fluoxetine on long-term growth in children," an FDA 1talk paper says...
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