Rx-to-OTC USA

Switch Sponsors Weigh Business Opportunities Against Regulatory Risk

In 2020, the U.S. market saw four new brands previously sold as prescription drugs enter the nonprescription market: 

  • Pataday allergy eye drops 
  • Voltaren Arthritis Pain topical NSAID 
  • Advil Dual Action ibuprofen and acetaminophen pain reliever 
  • Sklice lice treatment 

The new switch approvals have signaled a willingness on the part of regulators to be less conservative when it comes to OTC access to these medicines.  Nasal steroid switches, like Flonase and Rhinocort, along with the topical NSAID Voltaren Arthritis Pain and Sklice lice shampoo, are all in categories where switch activity was curtailed in the not-so-distant past due to concerns over systemic absorption of topically applied medicines. For in-depth profiles of recently approved FDA switches, subscribe to the all-new KlinePULSE Consumer Healthcare Industry Trends service. Continue reading

Recent Rx-to-OTC Switches in the U.S.

Five Newly Approved Switches Hit the U.S. Market

The U.S. FDA approved five new branded Rx-to-OTC switches in 2020, including eye drops, an external analgesic, and a lice treatment. In additionprivate-label companies such as Perrigo and Mylan gained approval for store brand versions of Voltaren Arthritis Pain Gel, Prevacid 24HR proton pump inhibitor, and Nicorette smoking cessation gum this year. These approvals come after a lull in switch activity during the past two years.  Continue reading

Rx-to-OTC Switches

The Three Most Important Considerations for Rx-to-OTC Switches: Safety, Safety, and Safety

When considering a potential switch, the FDA is tasked with weighing the benefits of enhanced access against the incremental risks greater access will pose. In doing so, the FDA will generally consider the efficacy and safety profile of a drug based upon the studies conducted to gain Rx approval, as well as the clinical knowledge gained from first-hand experience of the product usage on the Rx marketplace. In addition, the FDA requires additional studies with consumers demonstrating that they can use the product safely in an OTC setting without third-party intervention.Continue reading