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

New drug products from Glenmark Pharmaceuticals and Cipla Limited are therapeutic equivalents to Sunovion Pharmaceuticals’ Brovana Inhalation Solution, 15 mcg/2 mL.

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