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Drug maker Glenmark Pharma on Wednesday said it had received approval from the US health regulator for Arformoterol Tartrate Inhalation Solution, used to treat conditions like chronic bronchitis and emphysema, in the US market.
The approved product is a generic version of Brovana Inhalation Solution, 15 mcg/2 mL, of Sunovion Pharmaceuticals Inc.
“Glenmark Pharmaceuticals has received final approval by the United States Food and Drug Administration (USFDA) for Arformoterol Tartrate Inhalation Solution, 15 mcg/2 mL, unit-dose vials,” the company said in a regulatory filing.
Glenmark Pharma said the Arformoterol Tartrate Inhalation Solution, 15 mcg/2 mL, Unit-Dose Vials will be manufactured in 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 approximately USD 437.9 million.
Sanjeev Krishan, President, Glenmark North America said, “We are very excited to be one of the first generic companies to receive approval for such an important product for our customers.”
Glenmark’s current portfolio consists of 172 products authorised for distribution in the US marketplace and 44 abbreviated new drug applications’ pending approval with the USFDA.