According to Amneal Pharmaceuticals, the FDA has tentatively approved Amneal’s ANDA for a generic of Teva’s QVAR beclomethasone dipropionate HFA MDI, 40 μg/actuation and 80 μg/actuation, for the treatment of asthma. The company notes that the beclomethasone MDI is its first metered-dose inhaler product.
Teva’s QVAR Redihaler beclomethasone dipropionate breath-actuated MDI was approved by the FDA in 2017 and launched in the US in 2018. At that time, Teva discontinued sales of the previous version of QVAR, which had originally been approved in 2000. In 2014, the FDA approved the addition of a dose counter to the QVAR MDI.
Amneal Senior VP and Chief Scientific Officer, Affordable Medicines, Srinivas Kone commented, “Our first metered-dose inhalation product is a landmark achievement for Amneal. This milestone reflects years of dedicated work at our state-of-the-art respiratory facility and marks the beginning of an important new therapeutic category for Amneal. With additional inhalation programs advancing, we are well positioned to drive a new growth vector within our Affordable Medicines segment.”
Read the Amneal Pharmaceuticals press release
