Confidence Beyond Compliance

Switching a prescription (Rx) product to over-the-counter (OTC) status can be a commercially rewarding option for extending the life cycle of a mature product. While generic substitution is a disrupter in the prescription environment, a recognized brand name and improved access can be a plus for patients.

A successful Rx-to-OTC switch requires consideration of multiple, potentially complex, factors such as regulatory environment, safety and potential for misuse, product differentiation, and distribution.  PharmaLex is a worldwide leader in drug safety, with more than 30 years in pharmaceutical consulting services, including a decade of experience helping companies switch Rx products to OTC. We have worked with clients to evaluate and develop Rx-to-OTC switch applications in areas such as Eye Care, Sleep Aids, Pain Relief, Overactive Bladder, and Acne Treatment.

Our experienced team works closely with each client to address the critical component of product safety assessment. If an Rx-to-OTC switch is in your future, contact us to see how we can help extend the lifecycle of your product.

pharmalex User testing


Bao-Anh Nguyen-Khoa PharmD, MPH
Senior Manager, Pharmacovigilance, Epidemiology & Risk Management (PER-EPI)
PharmaLex US Corporation

Title: Safety considerations for an Rx to OTC Switch Program
Date: Wednesday, June 12, 2019 Time: 04:00 PM Central European Summer Time
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