The FDA has issued a new product-specific guidance for dihydroergotamine mesylate nasal spray and revised guidances for fluticasone propionate; azelastine hydrochloride/fluticasone propionate; mometasone furoate; and triamcinolone acetonide nasal sprays since February 1, 2019.
According to the agency, the latest batch of guidances issued includes a total of 74 drugs, with 49 of those being complex drugs. FDA Commissioner Scott Gottlieb said, “As the FDA works to help promote drug competition and patient access to affordable medicines, our efforts have been especially focused on complex drugs, which may be harder to genericize and often face less competition. In 2019, the agency will continue to advance policies to help promote competition in this space and help to reduce development time for complex generics.”
Guidances for mometasone furoate, fluticasone propionate and azelastine HCL/fluticasone propionate were issued in 2015. The previous guidance for triamcinonolone acetonide nasal spray was released in 2016.
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Read the FDA announcement.
View the guidance on DHE nasal spray.
View the guidance on fluticasone propionate nasal spray.
View the guidance on azelastine hydrochloride/fluticasone propionate nasal spray.
View the guidance on mometasone furoate nasal spray.
View the guidance on triamcinolone acetonide nasal spray.