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Cipla gets regulator’s nod to market its COPD drug in US

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Pharmaceutical company Cipla has received final consent from the US health regulator for Arformoterol Tartrate inhalation solution.

The approved product is used to treat conditions like chronic bronchitis and emphysema in the US market.

The company has received final approval for its abbreviated new drug application (ANDA) for Arformoterol Tartrate inhalation solution 15 mcg/2 mL from the United States Food and Drug Administration (US FDA), Cipla said in a regulatory filing on Wednesday (June 23).

It is a generic version of Sunovion Pharmaceuticals Inc’s Brovana.

Brovana is used in maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

Brovana had sales of around $438 million (£314m) in the US for the 12-month period ending April 2021.

The new product is available for shipping immediately, Cipla said.

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