Cipla receives final approval for generic version of Sunovion Pharmaceuticals, Inc.'s Brovana® (Arformoterol Tartrate Inhalation Solution 15 mcg/ 2mL)

June 23, 2021 |

2 min read

Cipla Limited announced that it has received final approval for its Abbreviated New Drug Application for Arformoterol Tartrate Inhalation Solution 15 mcg / 2 mL from the United States Food and Drug Administration.

MUMBAI, India, June 23, 2021 /PRNewswire/ -- Cipla Limited (BSE: 500087) (NSE: CIPLA EQ) (hereafter referred to as “Cipla”) today announced that it 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’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 $438M for the 12-month period ending April 2021.

The product is available for shipping immediately.

About Cipla:

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. Our strengths in the respiratory, anti-retroviral, urology, cardiology, anti-infective and CNS segments are well-known. Our 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. Cipla is ranked 3rd largest in pharma in India (IQVIA MAT April’ 21), 3rd largest in the pharma private market in South Africa (IQVIA MAT April'21), and is among the most dispensed generic players in the U.S. For over eight decades, making a difference to patients has inspired every aspect of Cipla’s work. Our paradigm- changing offer of a triple anti-retroviral therapy in HIV/AIDS at less than a dollar a day in Africa in 2001 is widely acknowledged as having contributed to bringing inclusiveness, accessibility and affordability to the centre of the HIV movement. A responsible corporate citizen, Cipla’s humanitarian approach to healthcare in pursuit of its purpose of ‘Caring for Life’ and deep-rooted community links wherever it is present make it a partner of choice to global health bodies, peers and all stakeholders. For more, please visit www.cipla.com, or click on Twitter, Facebook, LinkedIn.