The first authorized generic version of Perforomist® (formoterol fumarate inhalation solution; Mylan Specialty L.P.) 20mcg/2mL has been made available by Teva Pharmaceuticals.
Formoterol fumarate inhalation solution is a long-acting beta2-adrenergic (LABA) agonist indicated for long-term maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. It is not indicated to treat acute deteriorations of COPD or for the treatment of asthma.
Regarding safety, the use of LABA, including formoterol fumarate inhalation solution is contraindicated for use without an inhaled corticosteroid in patients with asthma. The most common adverse reactions (incidence of greater than or equal to 2% and more common than placebo) for formoterol fumarate inhalation solution are diarrhea, nausea, nasopharyngitis, dry mouth, vomiting, dizziness, and insomnia.
The generic product is supplied as 30- and 60-count cartons containing 2mL sterile solution for nebulization in 3mL unit dose vials.
“Teva is pleased to provide patients with first-to-market access to a generic version of Perforomist (formoterol fumarate inhalation solution),” said Christine Baeder, SVP, Chief Operating Officer US Generics, Teva USA.
- Teva announces its launch of the first generic Perforomist®, formoterol fumarate inhalation solution, 20 mcg/2 mL, used to treat chronic obstructive pulmonary disease (COPD), in the United States. [press release]. Tel Aviv, Israel & Parsippany, NJ: Teva Pharmaceuticals; June 22, 2021.
- Formoterol fumarate inhalation solution [package insert]. Parsippany, NJ: Teva Pharmaceuticals; 2020.