FDA accepts Teva's sNDA for pediatric QNASL

JERUSALEM — Teva Pharmaeceuticals on Tuesday announced that the Food and Drug Administration accepted the company's supplemental new drug application for a lower dose QNASL (beclomethasone dipropionate) nasal aerosol, which is used for the treatment of seasonal and perennial allergic rhinitis in children ages 4 years to 11 years.



QNASL, a waterless intranasal corticosteroid spray, is currently available to treat patients 12 years of age and older who show symptoms of seasonal allergic rhinitis and perennial allergic rhinitis, the company notes.



“We are very pleased the FDA has accepted for review the sNDA for QNASL. If the FDA approves the new indication for QNASL, it will become the first waterless HFA nasal allergy treatment approved for patients as young as 4 years of age,” said Tushar Shah, M.D., SVP at Teva Global Respiratory Research and Development. “The low-dose formulation demonstrates our commitment to the development of innovative treatment options for all patients with respiratory conditions, including nasal allergies.”