Calyptus receives FDA nod for generic Brovana
The Food and Drug Administration has given the green light to Calyptus’ partner, Vista Pharm, for a generic version of Brovana (arformoterol tartrate inhalation solution, EQ 0.015 mg base/2 ml). Calyptus co-developed the product in collaboration with VistaPharm.
Generic Brovana is indicated for the long-term, twice-daily (morning and evening) maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema.
[Read more: AAM report: Generics, biosimilars saved U.S. healthcare system $8B in 2020]
Arformoterol tartrate inhalation solution is for use by nebulization only, the company noted.
"We are thrilled with this approval in partnership with VistaPharm,” Calyptus co-founders Sujeet Singh, Puiho Yuen and Shubhayu Sinharoy said. “We believe that combining Calyptus' know-how and expertise with partners is key to bringing affordable medicines to patients and creating shared success. The successful development, and approval of a generic formulation of arformoterol tartrate inhalation solution is a testimony to these efforts.”
[Read more: Challenges continue, but generics companies see a bright future with biosimilars]
Arformoterol tartrate inhalation solution had a market value of approximately $104 million for the 12 months ending June 2022, according to IQVIA.