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Home » CDER: OTC Naloxone Must Show It Can Be Used Effectively With Labeling Alone
CDER: OTC Naloxone Must Show It Can Be Used Effectively With Labeling Alone
The FDA Thursday told stakeholders at a public hearing that manufacturers of naloxone may switch their products from prescription-only to over-the-counter as long as they can show that it can be used effectively by consumers guided by product labeling alone.