Accoding to Teva, the FDA has approved the company’s QNASL beclomethasone dipropionate HFA nasal spray for the treatment of allergic rhinitis symptoms in children aged 4-11. The supplemental NDA for the pediatric product was accepted by the FDA in May 2013.
The children’s version of QNASL is a 40 µg formulation; the adult version, which was approved in 2012, is an 80 µg/spray formulation. Teva says that the new nasal spray should be available in February 2015.
Teva Global Respiratory Research and Development Senior VP Tushar Shah commented, “The approval of this lower dose formulation of QNASL for children reaffirms Teva’s deep-rooted commitment to developing treatment options to help address respiratory conditions among all patient populations. Through the availability of QNASL 40 µg, we are aiming to aid children and their caregivers in better managing the burdensome symptoms associated with nasal allergies.”
Read the Teva press release.
