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US drug regulator gives nod to Cipla’s inhalation product

US drug regulator gives nod to Cipla's inhalation product


US drug regulator gives nod to Cipla’s inhalation product

Drug major Cipla on Wednesday said it has received final 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 Sunovion Pharmaceuticals Inc’s Brovana.

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

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Quoting IQVIA (IMS Health) data, Cipla said Brovana had US sales of approximately USD 438 million for the 12-month period ending April 2021. The product is available for shipping immediately, it added.

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