NEW DELHI (dpa-AFX) - Cipla Limited said that it has received final approval from the United States Food and Drug Administration for its Abbreviated New Drug Application or ANDA for Arformoterol Tartrate Inhalation Solution 15 mcg / 2 mL. The product is available for shipping immediately.
Cipla's Arformoterol Tartrate Inhalation Solution 15 mcg / 2 mL is AN-rated generic therapeutic equivalent version of Sunovion Pharmaceuticals Inc.'s Brovana.
Brovana is a long-acting beta-2 adrenergic agonist indicated for long-term, twice daily administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema.
According to IQVIA, Brovana had US sales of approximately $438 million for the 12-month period ending April 2021.
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