The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a new draft guidance for industry on generic naloxone hydrochloride nasal spray entitled ``Draft Guidance on Naloxone Hydrochloride.'' The new draft guidance, when finalized, will provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for naloxone hydrochloride nasal spray.
Document
Product-Specific Guidance for Naloxone Hydrochloride; New Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a new draft guidance for industry on generic naloxone hydrochloride nasal spray entit...
Legal Citation
Federal Register Citation
Use this for formal legal and research references to the published document.
82 FR 18913
Web Citation
Suggested Web Citation
Use this when citing the archival web version of the document.
“Product-Specific Guidance for Naloxone Hydrochloride; New Draft Guidance for Industry; Availability,” thefederalregister.org (April 24, 2017), https://thefederalregister.org/documents/2017-08199/product-specific-guidance-for-naloxone-hydrochloride-new-draft-guidance-for-industry-availability.