GSK Consumer Healthcare is a leader in the process of switching prescription medicines to over the counter (OTC) and has more than 25 years of experience in bringing healthcare opportunities into the OTC space. Nine of our switches have more than $100 million in annual retail sales today. Our Flonase® Allergy Relief switch significantly grew the allergy category and further strengthened our relationships with retail partners. We’ve even pioneered first-in-class switches, introducing brand new OTC categories to the market, such as weight loss and nicotine-replacement therapy products. These switch opportunities have won multiple awards for packaging, advertising and promotional campaigns.


Here’s how GSK Consumer Healthcare can assist your company’s Rx-to-OTC switch efforts:

  • Our experienced team will lead and drive the complete switch process, so your submission has the best chance for a successful approval.
  • Our multifunctional team of experts work collaboratively to gather and assess safety, efficacy, market research and other data generated to date.
  • We will take the lead in identifying and performing additional work and analyses that may be needed and create a regulatory strategy on when to proceed with FDA submission.
  • We have an extensive network of internal and external experts to build strong support for the required benefit-to-risk and safe consumer self-use evaluations.
  • Our commercial and R&D teams work together at each step, to ensure the focus always includes both switch approval and commercial success for the OTC product.
  • We have a full range of commercial capabilities, from developing the OTC strategy and brand communications to designing the right label, negotiating retail placement and executing the launch with excellence.
  • To support your product’s ongoing success, we leverage GSK's consumer and shopper insights, expert marketing capabilities, behaviour support programmes, new and evolving tools, and technology and more.


GSK's 25+ Years of Rx-to-OTC switch Experience*





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