Glenmark receives USFDA approval for Arformoterol Tartrate Inhalation Solution

Glenmark Pharmaceuticals has received final approval by the United States Food & Drug Administration (USFDA) for Arformoterol Tartrate Inhalation Solution, 15 mcg/2 mL, Unit-Dose Vials, the generic version of BROVANA Inhalation Solution, 15 mcg/2 mL, of Sunovion Pharmaceuticals Inc.

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.

According to IQVIATM sales data for the 12 month period ending April 2021, the BROVANA Inhalation Solution, 15 mcg/2 mL market achieved annual sales of approximately $437.9 million.

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