Cipla Limited announced that the FDA has issued final approval of an ANDA for the company’s generic version of GSK’s Imitrex 20 mg sumatriptan nasal spray. Cipla’s sumatriptan nasal spray is an AB-rated generic.
Imitrex nasal spray was first approved by the FDA in 5 mg, 10 mg, and 20 mg doses in 1997. Lannett’s ANDA for a generic version of the 5 and 20 mg dose levels was approved in 2016. That approval came in the midst of a shortage of sumatriptan nasal spray in the US. In 2018, the FDA issued a revised draft product specific guidance for generic versions of Imitrex.
The FDA also lists approved generics of the 20 mg Imitrex product from Perrigo and Pharmaserve NW.
Read the Cipla press release.
