INSYS Therapeutics (INSY +5.1%) is up on below-average volume in apparent reaction to a statement from FDA Commissioner Scott Gottlieb, M.D. supporting over-the-counter access for opioid overdose med naloxone, currently prescription-only.
The agency has taken the added step of developing a model Drug Facts Label (DFL) to aid developers in their regulatory submissions. A DFL is a set of instructions for consumers detailing the safe use of the product without the supervision of a healthcare professional.
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