The FDA approved once-daffy Veramyst (fluticasone furoate) nasal spray to treat symptoms of seasonal and perennial allergic rhinitis in patients aged 2 years and older.
Comment: Phase III studies of 1,112 children aged 2-11 years with seasonal or perennial allergies demonstrated the efficacy of Veramyst.
Five clinical trials with a total of 1,829 patients aged 12 years and older indicated that Veramyst was more effective than placebo in improvement of overall nasal symptoms.
For once-a-day treatment, consider Veramyst
nasal spray; to save money, consider nonprescription Zyrtec-D.
LOS ANGELES -- Under the category for "Dental instruments, equipment, and supplies," please note removal of the product Veramyst
and Avamys (Fluticasone Furoate) nasal spray delivery device (GlaxoSmithKline R&D).
CHICAGO -- Celsis International plc today announces that GlaxoSmithKline's New Drug Application (NDA) for Veramyst nasal spray, is the first approval of an NDA that references Celsis' Rapid Microbiological Method (RMM) as part of a regulatory submission.
The FDA's approval of Veramyst builds on acceptance of the Celsis Rapid Detection System as a microbiological in-process and end-product release testing method for pharmaceutical and biopharmaceutical products by other regulatory agencies around the world.
We are pleased that GlaxoSmithKline received FDA approval for Veramyst, where the Celsis system is its primary microbial screening method for end-product release," said Jay LeCoque, Chief Executive Officer of Celsis.