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

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, osteoarthritis, which increases with age, affects millions of people in the U.S., and can generally be self-diagnosed. Arthritis is the swelling and tenderness of one or more of the joints. Symptoms of arthritis include pain, swelling, stiffness, and difficulty moving a joint. This medication has been sold without a prescription safely for years in Europe and marks the first topical analgesic with anti-inflammatory properties available without a prescription in the United States. It also offers another non-opiate option for those suffering from chronic arthritis pain.   Continue reading