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The FDA has accepted Harm Reduction Therapeutics’ (HRT) new drug application (NDA) for RiVive, an investigational over-the-counter (OTC) nasal spray containing 3 mg of naloxone, and has granted the drug-device combination a priority review.
The De Novo pathway is an option for applicants with novel medical devices which are considered reasonably safe and effective under certain controls, but have no legally marketed predicate device.