Aurobindo Pharma receives US FDA nod for metered Beclomethasone Dipropionate aerosol
Mumbai, Sept. 15 -- The approved ANDA is a generic equivalent of QVAR Inhalation Aerosol, marketed by Teva Branded Pharmaceutical Products R&D LLC.
Beclomethasone Dipropionate HFA Inhalation Aerosol is indicated in the maintenance treatment of asthma as prophylactic therapy in patients 5 years of age and older. Indicated for asthma patients who require systemic corticosteroid administration, where adding Beclomethasone Dipropionate HFA Inhalation Aerosol may reduce or eliminate the need for the systemic corticosteroids.
The product will be manufactured at Aurobindo Pharma's Raleigh facility in North Carolina, owned by its wholly owned step-down subsidiary Aurolife Pharma LLC. The product is expected to be launched in upcoming quarters....
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