US Proposed ACNU Rule Rings Bell About Rx Drugs Marketed After NDAs Eliminated With OTC Switches
Proposal for simultaneous Rx and OTC sales of same drug at same dose and indication has CHPA hoping FDA acknowledges Pataday and Voltaren Arthritis Relief are competing with Rx equivalents even though elimination of prescription NDAs was part of approvals for the two switches.
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Rx-To-OTC Switch Of Low-Cost Smoking Cessation Drug Cystine Rejected By German Committee
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.
Alternative Smoking Cessation Drug Cytisine On 2023 German Switch Committee Agenda
Low-cost alternative smoking cessation drug cytisine is under consideration by Germany's independent switch committee in January, alongside azelastine and fluticasone propionate in combination for intranasal use, olopatadine for ophthalmic use and bilastine (10mg) for oral use.
Rx Naloxone Marketer's OTC Switch Proposal For Nasal Spray Gets Priority Review From FDA
Emergent BioSolutions’ announcement of FDA accepting sNDA for an OTC 4-mg naloxone nasal spray marks another recent step in agency’s response under Commissioner Califf to Capitol Hill pressure to expand availability of topioid antagonist to help curb opioid overdose death epidemic.