- In September 2024, Haleon, plc received U.S. FDA approval for Eroxon, a gel for the treatment of erectile dysfunction (ED). This marks a significant development as it is the first and only cleared OTC product for erectile dysfunction. This highlights a trend towards making more complex and previously prescription-only treatments available to consumers over-the-counter
- In August 2024, the U.S. FDA announced the approval of the First to Know a Home, over-the-counter syphilis diagnostic test by NOWDiagnostics. This is a first-of-its-kind kit to detect Treponema pallidum (syphilis) antibodies in human blood, underscoring the growing market for OTC diagnostic tests and empowering individuals with more immediate health insights
- In 2023, India began moving closer to establishing a streamlined regulatory framework for OTC drugs. The Drugs Technical Advisory Board (DTAB) approved recommendations from a special OTC sub-committee, proposing around 27-30 drugs (primarily analgesics, topical ointments, and cough-and-cold medications) for inclusion in India's first comprehensive OTC drugs list. This initiative also aims to allow pharmaceutical companies to advertise these brands, increasing public awareness and potentially reducing healthcare costs
- In 2023, the OTC market witnessed a strong focus on new drug formulations and enhanced delivery systems. Companies are developing fast-dissolving tablets, chewable pills, dissolvable strips, and nasal sprays to improve user experience, speed up onset of action, and offer more convenient administration methods. There's also an increasing integration of technology, such as mobile apps and wearable devices, to improve medication adherence and track health metrics
- In July 2023, several key product switches from prescription (Rx) to OTC status significantly impacted the market, particularly in North America. Notably, the accessibility of the emergency contraceptive pill, Plan B One-Step, without age restrictions, and the approval of Narcan and RiVive (naloxone nasal sprays for emergency opioid overdose treatment) and Opill (a progestin-only oral birth control pill, the first of its kind available without a prescription in the U.S.) have driven market growth by increasing consumer access to essential medications
