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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
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 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.
Recently, in Europe and Japan there have been increased Rx-to-OTC switch approvals and an environment fostering switch. The OTC men’s health category is growing in Europe, with the switch approval of Recordati’s Fortacin (lidocaine 7.5mg/prilocaine 2.5 mg) spray for premature ejaculation, via the centralized switch procedure through the European Medicines Agency. This drug marks the fifth medicine approved for switch through this centralized regulatory body, and it is expected to be launched throughout the EU on a nonprescription basis
Recently released data from our Nonprescription Drugs USA study shows that the U.S. nonprescription drugs industry posted moderate growth in 2014, recording revenue growth for the sixth consecutive year. Estimated at $24+ billion at the manufacturers’ level, the market climbs by 1.4% from 2013 to 2014. Out of the seven product classes we track, five
In 2014, two intranasal steroids for the treatment of allergic rhinitis received FDA approval for Rx-to-OTC switch—Sanofi’s Nasacort Allergy 24 Hour and GlaxoSmithKline’s Flonase Allergy Relief. Nasacort entered the OTC market in February 2014 and according to recently released data from Kline’s Nonprescription Drugs USA study, from February through December 2014, the product generated about
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, using unique approaches and technology to support the approval of new switches and safe use of consumer OTC medications. “There is excitement and new Rx-to-OTC switch possibilities being evaluated in
