Lannett Obtains FDA Approval For Sumatriptan Nasal Spray USP, 5mg And 20mg

(RTTNews) - Lannett Company Inc. (LCI) announced that it has received approval from the U.S. Food and Drug Administration of its Abbreviated New Drug Application (ANDA) for Sumatriptan Nasal Spray USP, 5 mg/spray and 20 mg/spray, the therapeutic equivalent to the reference listed drug Imitrex® Nasal Spray, of GlaxoSmithKline. According to IMS, total U.S. sales in 2015 of Sumatriptan Nasal Spray USP, 5 mg/spray and 20 mg/spray at Average Wholesale Price (AWP) were approximately $62 million.

The company expects to commence marketing the product in the next several months.