Teva has announced the FDA’s acceptance of its supplemental NDA for a low-dose formulation of QNASL beclomethasone dipropionate HFA nasal spray for the treatment of allergic rhinitis in children aged 4-11. The FDA approved QNASL for the treatment of seasonal and perennial allergic rhinitis in patients 12 and older in March 2012.
Teva Senior VP Global Respiratory Research and Development Tushar Shah commented, “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. The low-dose formulation demonstrates our commitment to the development of innovative treatment options for all patients with respiratory conditions, including nasal allergies.”
Read the Teva press release.
