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Home » FDA Allows In Vitro Studies to Prove Generic Naloxone Bioequivalence
FDA Allows In Vitro Studies to Prove Generic Naloxone Bioequivalence
For the development of generic versions of naloxone, an emergency nasal spray treatment for opioid overdoses, the FDA said it will allow sponsors to demonstrate bioequivalence using solely in vitro performance tests — as long as the generic is qualitatively the same as the reference product.