Esketamine (Spravato) and sumatriptan (Tosymra) nasal sprays are among the latest set of product specific draft guidances published by the FDA. Earlier this year, the agency published a product specific guidance for sumatriptan nasal powder. The August 2020 revised product guidances include budesonide nasal spray and ketorolac tromethamine nasal spray.
In addition, the FDA updated its list of upcoming product specific guidances for complex generics. OINDPs included on that list include desmopressin acetate nasal spray (Noctiva), diazepam nasal spray (Valtoco), epinephrine MDI (Primatene Mist), fluticasone propionate nasal spray (Xhance), midazolam nasal spray (Nayzilam), olodaterol/tiotropium bromide (Stiolto Respimat), tiotropium bromide (Spiriva Respimat), and tobramycin inhalation powder (TOBI Podhaler).
