Rx-to-OTC Switch
Huge opportunities for OTC therapies loom in India, as consumerization brings structural reset in healthcare. Success stories on Rx-to-OTC transition augur well for pharma, but a predictable regulatory roadmap will be pivotal for sustainable growth.
In PDUFA reauthorization subgroup meetings, CHPA suggests expanding FDA’s special protocol assessment program to include OTC drug studies before FDA notes Congress has required it to provide switch-specific guidance before current PDUFA expires.
Germany’s Expert Committee for Prescription meets on 20 January to discuss the Rx-to-OTC switch of controversial painkiller metamizole, which has been banned in a number of countries around the world because of the risk of agranulocytosis.
The US FDA is signaling its willingness to consider ‘creative’ proposals to make epinephrine available over-the-counter to treat anaphylaxis. The naloxone OTC switch may be a model, and the new ‘ACNU’ pathway could help.
Agency intends to use information from comments to guide its planning for a public meeting during 2026, according to a Federal Register notice. A GAO report is due in a year to Congress profiling FDA’s progress on making more drugs available nonprescription through OTC switch applications.
UK consumer healthcare industry association, PAGB, suggests improvements that could help accelerate Rx-to-OTC switch in the country.
A new cohort of “techno-enthusiasts” who are highly susceptible to misinformation and inappropriate self-care decisions are undermining Italy's responsible self-medication model, finds a report by Italian self-care industry association, Assosalute, and independent researcher Censis.
Negative growth in global OTC market sales volume means that “as an industry, we're not doing good enough,” argues Opella’s Asia Pacific, Middle East and Africa (AMEA) head, Carol-Ann Stewart, in this exclusive feature interview.
Approval of numerous Rx formulations hasn’t translated to wider availability when a remedy is needed for anaphylaxis emergency, say FDA and the Margolis Institute in announcing workshop on reducing anaphylaxis-related morbidity and mortality.
Self-Care Week Special: HBW Insight catches up with PAGB CEO Michelle Riddalls OBE to talk about what the association is doing to promote Rx-to-OTC switch in the UK.
The global allergy market is “expanding again but on new terms, driven by a mix of regional strength, evolving consumer behaviors, and an increasingly diverse competitive field,” according to the latest IQVIA Consumer Health analysis.
Japan’s Ministry of Health, Labor and Welfare continues to widen access to non-prescription medicines with another Rx-to-OTC switch – Rohto Algard Epinastine Eye Drops – and a direct OTC approval of Sato Pharmaceutical's Menofeminin (black cohosh) menopause treatment.
Cemag Care may be behind the recent Rx-to-OTC switch of menstrual health treatment tranexamic acid (1000mg) in France.
“Women's health isn't a niche area," noted Perrigo’s Alison Slingsby at Lynx2Market’s PharmaSynergyOTC event in Rome. Slingsby offers advice from the firm's experience in delivering some of the most innovative women's health Rx-to-OTC switches.
Opella's Japanese subsidiary, SSP Pharmaceuticals, has had an Rx-to-OTC switch application for ED drug Cialis approved by the national regulator.
Aska Pharmaceutical has recieved a green light from Japan’s Ministry of Health, Labour and Welfare for the Rx-to-OTC switch of its NorLevo (1.5mg levonorgestrel) emergency contraceptive. Controversially, OTC NorLevo will need to be taken on the spot by purchasers in the presence of a pharmacist.
In an exclusive Q&A, HBW Insight catches up with Maxwellia CEO Anna Maxwell to find out more about the UK Rx-to-OTC switch of Naprosyn Pain Relief, the first new OTC single-ingredient oral analgesic for acute back, muscle and joint pain in over a decade.
Thanks to a successful reclassification by Maxwellia, UK consumers have a new option for relief from musculoskeletal pain.
Amphastar confident Primate Mist asthma spray will lose little market share to eventual generic competitors because it’s developing a propellant with a lower ozone-depleting impact. Also looks for US OTC market revenues from proposed naloxone nasal spray.
Norway becomes the third European country to approve OTC sales of tadalafil. Cialis reseptfri will “soon be on shelves,” Opella says, with the launched being planned in partnership with Stada Arzneimittel.