Focus on Rx-OTC Switches

Case Studies on Opill and Naloxone: Key Takeaways from the Latest Switch Approvals and What They Mean for Future Industry Opportunities

January 24, 2024 9:15am

Kyle Y. Faget
Partner
Foley & Lardner LLP

Amy Replogle
Director, Rx-to-OTC Switch
Bayer

Deborah Livornese
Partner
Hyman, Phelps & McNamara P.C.

FDA’s recent efforts to enhance accessibility to OTC drug products have set the stage for a wave of approved switches in the industry – a development being warmly embraced by non-prescription drug companies. This panel will:

  • Analyzing the high-profile switches shaping the OTC industry landscape
    • Opill
    • Naloxone
  • Explore what FDA has considered in approving the latest switches and hurdles industry may face in obtaining future switches
  • Assessing the significance of the Opill switch and its implications on new opportunities for RX-OTC switches, particularly in the area of women’s health