Cipla gets USFDA nod for generic version of Brovana
Mumbai: Drug major, Cipla Limited, today announced that 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 (USFDA).
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.
Cipla Limited is an Indian multinational pharmaceutical and biotechnology company, headquartered in Mumbai, India. The Company was founded by Khwaja Abdul Hamied in 1935 in Mumbai.
Cipla primarily develops medicines to treat respiratory, cardiovascular disease, arthritis, diabetes, weight control, depression, and other medical conditions.
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