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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 addition, private-label companies such as Perrigo and Mylan gained approval for
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
In contrast to the U.S. FDA, regulatory agencies outside the United States have been much more aggressive in approving switches for conditions outside the typical
With the publication of FDA’s NSURE (Nonprescription Safe Use Regulatory Extension) in February 2012, the pharmaceutical industry has been buzzing with potential for new switches,
Analyzing and forecasting Rx-to-OTC switch sales for over 50 years at Kline, we have recently reviewed how accurate our forecasts have been over time. Over
