According to Aurobindo Pharma, the FDA has issued a final approval of the company’s ANDA for 40 mcg and 80 mcg dose versions of a generic equivalent of Teva’s QVAR beclomethasone HFA MDI for the treatment of asthma. The announcement notes that the MDI will be manufactured by its subsidiary Aurolife Pharma at Aurolife’s facility in Raleigh, North Carolina, USA.
Aurobindo points out that the approval is its first for an metered dose inhaler, saying, “Building on our leadership in generics, we are now expanding into complex inhalation therapies to create the next wave of differentiated growth in the US market.”
Earlier this year, Amneal also launched a generic version of the QVAR HFA MDI. Teva had discontinued QVAR HFA after its QVAR Redihaler beclomethasone dipropionate breath-actuated MDI was approved by the FDA in 2017 and launched in the US in 2018.
Read the Aurobindo press release
