The Food and Drug Administration (FDA) is announcing the availability of a new draft guidance for industry on generic naloxone hydrochloride nasal spray entitled “Draft Guidance on Naloxone Hydrochloride.” The new draft guidance, when finalized, will provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new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.
The new draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The new draft guidance, when finalized, will represent the current thinking of FDA on the design of BE studies to support ANDAs for naloxone hydrochloride nasal spray. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.
More information is available via the Federal Register notice.