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Tag: FDA approvals

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

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New FDA Approvals

Switch Activity Heating Up with New OTC Approvals

The U.S. FDA announced approval of three Rx-to-OTC switches on February 14, 2020. One is GlaxoSmithKline’s OTC version of its topical nonsteroidal anti-inflammatory (NSAID) pain reliever, Voltaren Gel (diclofenac sodium topical gel, 1%). This OTC medication will be indicated for temporary relief of joint pain and stiffness due to the most common type of arthritis,

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