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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Republicans Robert Latta and Dan Crenshaw and Democrat Debbie Dingell are members of House Energy and Commerce Committee’s Health Subcommittee, predominant source of legislation affecting FDA operations.
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.
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.