Revised draft guidances for sumatriptan and zolmitriptan nasal sprays are included in the most recent batch of product-specific guidances for generic drug development issued by the FDA. The agency says that it “publishes these product-specific guidances to foster drug product development, and ANDA submission and approval, ultimately providing increased access to safe, affordable generic drugs.”
The draft guidance for sumatriptan nasal spray was initially published in March 2012. GSK’s Imitrex sumatriptan nasal spray was approved for the treatment of migraine headaches in 1997, and Lannett’s ANDA for a generic version was approved in 2016.
The draft guidance for zolmitriptan nasal spray was first published in July 2014. AstraZeneca’s Zomig nasal spray was approved for the treatment of migraine headaches in 2003, and there are currently no generics approved in the US.
Lannett filed an ANDA for a generic zolmitriptan nasal spray in 2014 and was immediately sued by Impax Laboratories, which had acquired US rights to Zomig in 2012. In March 2017, a US District Court judge ruled that Lannett had infringed on patents related to Zomig, and that ruling was upheld earlier this year, after Impax was acquired by Amneal.
View the revised draft guidance for sumatriptan nasal spray.
View the revised draft guidance for zolmitriptan nasal spray.
