Cipla Limited has received final approval for its Abbreviated New Drug Application (ANDA) for generic version of Brovana i.e. Arformoterol Tartrate Inhalation Solution 15 mcg/2 mL from the United States Food and Drug Administration (US FDA).

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 (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 US $438 million for the 12-month period ending April 2021.

The product is available for shipping immediately.

Established in 1935, Cipla is a global pharmaceutical company focused on agile and sustainable growth, complex generics, and deepening portfolio in our home markets of India, South Africa, North America, and key regulated and emerging markets. The company's strength lies in the respiratory, anti-retroviral, urology, cardiology, anti-infective and CNS segments. Cipla's 46 manufacturing sites around the world produce 50+ dosage forms and 1,500+ products using cutting-edge technology platforms to cater to our 80+ markets.