title: Rx-to-OTC switches: trends and factors underlying success.
abstract: The US Food and Drug Administration defines an Rx-to-OTC switch as over-the-counter (OTC) marketing of a drug product that was once a prescription (Rx) drug for the same indication, with the same strength, dose, duration of use, dosage form, population and route of administration. Here, we examine the rationale behind switches, the process of switches and historical case studies of switches in the United States to understand the factors for success and expected future trends.
authors.affiliation: Kline & Co., Little Falls, New Jersey 07424-0410, USA. Laura_Mahecha@klinegroup.com
authors.forename: Laura A
authors.initials: LA
authors.lastname: Mahecha
mesh_terms: D000329:Advertising; D004345:Drug Industry / Q000639:trends; D011307:Drug Prescriptions / Q000191:economics; D004366:Nonprescription Drugs / Q000191:economics; D010330:Patents as Topic; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D004366:Nonprescription Drugs