Rx-to-OTC Switch

Low-cost smoking cessation alternaitve cystine and azelastine-fluticasone combination nasal spray Rx-to-OTC switch applications were rejected by Germany's independent Expert Committee on Prescription at its latest meeting. Olopatadine for ophthalmic use and oral bilastine at 10mg strength were, however, given the green light. 

Could codiene linctus cough syrups be reverse-switched from OTC to Rx status in the UK? A panel of independent medicines experts suggests they should be, based on UK drugs law and their use in illegal cocktail Purple Drank.

OTC drug and dietary supplement industry trade group executives discuss questions on potential market and regulatory developments affecting their members’ businesses. HBW Insight reports on OTC drug sector’s outlook for the FDA potentially publishing a final rule to expand switch opportunities as well as its anticipation of marketplace results from monograph program overhaul.

Demand for OTC pain relievers and cough/cold products jumped prior to October-December and remained high during quarter due to consumer concern not only about flu but also RSV and additional COVID-19 mutation. US and Canadian firms marketing OTC drugs and supplements also will be offering additional signals on planned spinoffs of consumer health businesses.

Agency has comments from Public Citizen, National Center for Health Research and American Heart Association to consider among 182 submitted on proposed published in June. FDA set a non-binding target date of October to publish “Nonprescription Drug Product With an Additional Condition for Nonprescription Use” final rule.

Ever since Australia's Therapeutic Goods Administration removed the prescription requirement for CBD, the race has been on to launch the world's first OTC CBD medicine. The UK's Chanelle McCoy Health has joined Haleon and local players McCann and Little Green Pharma in testing CBD for sleep with an eye on a 2023 product launch.

Priority review pushes up to 29 March FDA’s deadline for decision on Emergent’s sNDA for OTC Narcan nasal spray. Agency schedules joint advisory committee on proposal for 15 February.

In January, the Dutch Parliament will debate an amendment to the country's medicines legislation that proposes to remove the requirement for a druggist or assistant druggist to be physically present during the sale of self-care medicines. The move will once again allow supermarkets to sell UAD medicines, with the help of digital tablets offering professional advice, hastening the transformation of the Dutch OTC market, according to Neprofarm's Bernard Mauritz.