On June 23, 1960, the U.S. Food and Drug Administration (FDA) approved Enovid (norethynodrel combined with mestranol) for use as an oral contraceptive, a milestone that transformed reproductive health, medical practice, and social debates about contraception. Developed from earlier hormonal research and clinical trials in the 1950s, Enovid had been marketed for menstrual disorders before the FDA’s approval for contraceptive use formalized its role as the first oral birth control pill available by prescription in the United States. Scientific and medical context The pill was the product of decades of hormonal research. Scientists had been studying synthetic steroids and the role of ovarian hormones in regulating menstruation and ovulation since the 1930s and 1940s. By the 1950s, researchers—including Gregory Pincus, John Rock, and others collaborating with pharmaceutical company G.D. Searle—had designed formulations that suppressed ovulation reliably when taken daily. Clinical trials in the 1950s, including studies in the United States and abroad, provided evidence of the pill’s high efficacy in preventing pregnancy when used as directed. Regulatory approval and labeling The FDA’s 1960 approval specifically authorized Enovid for menstrual disorders and for contraceptive use; earlier versions of the drug had been prescribed for menstrual regulation. The labeling and recommended use required administration by prescription and monitoring by physicians. The approval reflected the agency’s assessment that the drug’s benefits—effective pregnancy prevention for women—outweighed known risks when used under medical supervision. Impact and uptake The pill’s availability catalyzed rapid changes in family planning. Within a few years, millions of women in the United States were able to obtain prescriptions, markedly increasing contraceptive choices beyond barrier methods and sterilization. The pill provided a highly effective, reversible option that allowed many couples to plan family size and timing more reliably. This had broad social and economic effects: increased opportunities for women’s education and workforce participation have been linked in subsequent scholarship to access to reliable contraception. Risks, controversies, and evolving understanding From the outset, physicians and regulators cautioned about potential side effects. Early high-dose formulations were later associated with increased risks of blood clots and other adverse events for some users. Over the 1960s and 1970s, clinical research and epidemiological studies refined understanding of risks and led manufacturers to develop lower-dose formulations with improved safety profiles. The pill also became a flashpoint in public debates about sexual morality, women’s rights, and the role of government and medicine in reproductive decisions. Legal and political battles—over access, prescription requirements, and insurance coverage—followed in subsequent decades. Historical significance The FDA’s 1960 approval of Enovid as an oral contraceptive is widely regarded by historians and public-health scholars as a turning point in reproductive health. It expanded medical options for women, influenced demographic trends, and intersected with the broader movements for women’s rights and sexual autonomy. The approval did not end controversy or risk: it initiated an era of ongoing research, regulation, and social negotiation around contraceptive technology. Notes on sources and interpretation This summary is based on historical and public-health literature documenting the development and regulatory history of oral contraceptives in the mid-20th century, including FDA records and peer-reviewed historical analyses. Specific details—such as formulation names and dates of labeling changes—are matters of public record; some aspects of early clinical trials and the roles of individual actors have been the subject of extensive historical study and discussion.