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Oxytrol For Women Gets OTC Green Light As Rare First-In-Class Switch

This article was originally published in The Tan Sheet

Executive Summary

FDA approved Merck’s overactive bladder drug Oxytrol for Women for OTC use, despite concerns raised by the Nonprescription Drug Advisory Committee in November. The company plans a launch in the fall.

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Dermatology Among Emerging Rx-To-OTC Switch Categories

FDA threw the switch floodgates open with the Nonprescription Safe Use Regulatory Expansion (NSURE) initiative and has fueled interest with recent first-in-class switches of Nasacort and Oxytrol for Women. Experts say likely categories for successful switches include dermatology, as drugs for treating eczema, acne and other skin conditions typically do not have systemic effects and address ailments that are readily recognized and understood by consumers.

Fears Of Too Many OTC Choices Should Not Restrict Switches, Stakeholders Say

FDA and its advisory committees should not meddle with the free market by potentially limiting Rx-to-OTC switches based on how crowded a self-care category is or by removing “obsolete” ingredients from the market once new, improved treatments become available, stakeholders argue.

Fears Of Too Many OTC Choices Should Not Restrict Switches, Stakeholders Say

FDA and its advisory committees should not meddle with the free market by potentially limiting Rx-to-OTC switches based on how crowded a self-care category is or by removing “obsolete” ingredients from the market once new, improved treatments become available, stakeholders argue.

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