FDA Has Model Drug Facts Labels For OTC Naloxone, Wants Switch Proposals
Development of the model DFLs was a first for agency, reflecting alarm over public health crisis of overdoses from opioid abuse, which reached nearly 48,000 in 2017. The project was "part of our broader commitment to addressing the opioid crisis" and should help sponsors with potential naloxone OTC switch NDAs, says Commissioner Scott Gottlieb.
You may also be interested in...
Committee report again includes item concerning FDA’s work on expanding access to opioid antagonist naloxone. It still doesn’t acknowledge agency’s interest in making drug available OTC in a nasal inhaler, but emphasizes access for pregnant and postpartum women.
Up to $6.5m funding will completely cover Harm Reduction Therapeutics' costs for a Phase 1 study, preparation of an NDA and commercial launch production. The study, a standard Phase 1 biocompatibility trial with around 30 subjects, should be completed in a few months later this summer.
FDA approved sNDAs from GlaxoSmithKline for diclofenac-containing Voltaren Arthritis Pain for the temporary relief of arthritis pain and from Alcon for Pataday olopatadine drops at 0.2% concentration for once-daily use temporary relief of itchy eyes due to pollen, ragweed, grass, animal hair or dander and 0.1% for twice-daily use for the same indications plus redness relief.