Lilly To Receive Six Additional Months Of Prozac Market Exclusivity

OPEN MINDS, The Behavioral Health & Social Service Industry Analyst Industry News The U.S. Food and Drug Administration (FDA) has granted Eli Lilly and Company an additional six months of market exclusivity for its antidepressant Prozac. Under the FDA Modernization Act of 1997, pharmaceutical companies that comply with FDA requests to submit specific pediatric studies on selected medications may qualify for an additional six months of market exclusivity for those products. The agency requested that such studies be submitted for Prozac, because there is a lack of data available regarding the effects of medications in treatment of child and . . .