Category: Society & Economics Key figures: Ray Fuller, Bryan Molloy, David T. Wong (Eli Lilly research team); Frank Young (FDA Commissioner, 1987)
On December 29, 1987, the U.S. Food and Drug Administration approved fluoxetine hydrochloride — marketed as Prozac by Eli Lilly and Company — for the treatment of major depressive disorder, making it the first selective serotonin reuptake inhibitor (SSRI) approved in the United States. The drug went on sale in January 1988.
Fluoxetine was synthesized in the early 1970s at Eli Lilly’s research laboratories. Bryan Molloy and Robert Rathbun synthesized the compound, while David T. Wong and Ray Fuller characterized its selective action on serotonin transporters. Earlier antidepressants — tricyclic antidepressants and monoamine oxidase inhibitors (MAOIs) — were effective but produced significant cardiovascular, sedative, and anticholinergic side effects. Fluoxetine’s greater selectivity for the serotonin reuptake system reduced those risks, making it both safer and more tolerable for a broader population of patients.
Clinical trials submitted to the FDA demonstrated efficacy in reducing depressive symptoms, and the agency’s approval opened what would become one of the most consequential pharmaceutical markets of the late twentieth century. By 1994, approximately six million Americans had been prescribed Prozac. A 1990 Newsweek cover story — “Prozac: A Breakthrough Drug for Depression” — signaled its entry into mainstream culture. Psychiatrist Peter Kramer’s 1993 book Listening to Prozac brought the drug and the broader SSRI class to wide public awareness, sparking debate about the medicalization of personality and emotional states.
The FDA approval of Prozac in 1987 transformed the treatment of depression and reshaped the pharmaceutical landscape. The SSRI class it inaugurated became the dominant first-line treatment for depression, anxiety disorders, and obsessive-compulsive disorder worldwide. The drug’s success prompted Eli Lilly competitors to develop their own SSRIs (sertraline/Zoloft in 1991, paroxetine/Paxil in 1992), establishing the class as the standard of care. Beyond pharmacology, Prozac’s cultural prominence accelerated public discourse about mental illness, reduced some stigma around seeking treatment, and fueled debate over whether psychiatric medications alter personality rather than merely treat disease. Critics also raised concerns about over-prescribing and long-term dependence, issues that remain active in clinical and policy discussions.