Cipla receives USFDA nod for a generic version of Brovana

Drug major Cipla Limited on Wednesday, June 23, 2021, announced that it has received final approval for its Abbreviated New Drug Application (ANDA) for Arformoterol Tartrate Inhalation Solution from the United States Food and Drug Administration (US FDA).

Cipla's Arformoterol Tartrate Inhalation Solution 15 mcg / 2 mL is an AN-rated generic therapeutic equivalent version of Sunovion Pharmaceuticals Inc.'s Brovana.

Brovana is a long-acting beta-2 adrenergic agonist (beta-2 agonist) indicated for:

 • Long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary      disease (COPD), including chronic bronchitis and emphysema.

 • According to IQVIA (IMS Health), Brovana had US sales of approximately $438M for the 12-month period ending April 2021.

Cipla in a regulatory filing said, "Cipla receives final approval for a generic version of Sunovion Pharmaceuticals, Inc.'s Brovana® (Arformoterol Tartrate Inhalation Solution 15 mcg/ 2mL) from the United States Food and Drug Administration (US FDA)."

The product is available for shipping immediately.