The approved product may be a generic version of Brovana Inhalation Solution, 15 mcg/2 mL, of Sunovion Pharmaceuticals Inc.
"Glenmark Pharmaceuticals has received final approval by the us Food and Drug Administration (USFDA) for Arformoterol Tartrate Inhalation Solution, 15 mcg/2 mL, unit-dose vials," the corporate said during a regulatory filing.
Glenmark Pharma said the Arformoterol Tartrate Inhalation Solution, 15 mcg/2 mL, Unit-Dose Vials are going to be manufactured within the company's North American manufacturing facility based in Monroe, North Carolina, and marks the company's first nebulizer approval.
Quoting IQVIA sales data for the 12 months period ending April 2021, the Brovana Inhalation Solution, 15 mcg/2 mL market achieved annual sales of roughly USD 437.9 million.
Sanjeev Krishan, President, Glenmark North America said, “We are very excited to be one among the primary generic companies to receive approval for such a crucial product for our customers.”
Glenmark's current portfolio consists of 172 products authorised for distribution within the US marketplace and 44 abbreviated new drug applications’ pending approval with the USFDA.
