Generic Inhalation Therapy for Bronchoconstriction in Patients With COPD Approved by FDA

Officials with the FDA have approved 2 new generic arformoterol tartrate inhalation solution drug products in 15 mcg/2 mL unit-dose vials. These drug products, from Glenmark Pharmaceuticals and Cipla Limited, are therapeutic equivalents to Sunovion Pharmaceuticals’ Brovana Inhalation Solution, 15 mcg/2 mL.^1,2

According to Sunovion, arformoterol tartrate inhalation solution is a long-acting beta₂-adrenergic agonist indicated for the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including bronchitis and emphysema. This long-term therapy is administered twice daily and is not indicated to treat acute deterioration of COPD nor asthma.³

The most common adverse reactions, occurring in 2% or more of patients receiving arformoterol tartrate inhalation solution compared with placebo, are pain, diarrhea, sinusitis, leg cramps, dyspnea, rash, flu syndrome, peripheral edema, and lung disorder, according to Sunovion.³

Cipla’s arformoterol tartrate inhalation solution is immediately available, according to the company.¹

Glenmark’s arformoterol tartrate inhalation solution will be manufactured in the company’s North American facility in Monroe, North Carolina, and marks the first FDA approval of a nebulizer medication.²

IQVIA sales data for the 12-month period ending April 2021 indicates national annual sales of approximately $437.9 million for Sunovion’s arformoterol tartrate inhalation solution, 15 mcg/2 mL market.^1,2

REFERENCES

1. Cipla receives final approval for generic version of Sunovion Pharmaceuticals, Inc.'s Brovana® (Arformoterol Tartrate Inhalation Solution 15 mcg/ 2mL) [news release]. June 23, 2021; Cipla Limited. Accessed June 23, 2021. https://www.prnewswire.com/news-releases/cipla-receives-final-approval-for-generic-version-of-sunovion-pharmaceuticals-incs-brovana-arformoterol-tartrate-inhalation-solution-15-mcg-2ml-301318132.html
2. Glenmark Pharmaceuticals receives ANDA approval for Arformoterol Tartrate Inhalation Solution, 15 mcg/2 mL, Unit-Dose Vials [news release]. June 23, 2021; Glenmark Pharmaceuticals. [email]
3. Brovana prescribing information. Sunovion Pharmaceuticals. Revised May 2019. Accessed June 23, 2021. https://www.brovana.com/brovana-approved-labeling-text.pdf