Cipla and Glenmark Pharmaceuticals have announced that they have received final approval from the FDA for generic versions of Sunovion’s Brovana arformoterol tartrate inhalation solution for the treatment of COPD. Cipla said that its product is available immediately. Glenmark noted that the approval is its first for a nebulized product and said that it will manufacture the inhalation solution at its facility in North Carolina.
In addition to the Cipla and Glenmark ANDAs, the FDA had also tentatively approved ANDAs for generic arformoterol tartrate inhalation solution from Teva and Axar Pharma. The FDA tentatively approved Lupin’s ANDA for the inhalation solution in April 2020, and in June 2021, Lupin launched an authorized generic of Brovana.
Sepracor (later Sunovion) submitted an NDA for Brovana in 2005, which was initially approved in 2006 with a requirement for a postmarketing safety study. Sepracor was then sued by Dey Pharma (later Mylan Specialty), which alleged that Brovana infringed on patents covering Perforomist formoterol fumarate inhalation solution. Mylan and Sepracor settled that suit in May 2012.
Glenmark North America President Sanjeev Krishan commented, “We are very excited to be one of the first generic companies to receive approval for such an important product for our customers. This also marks our third approval from our state-of-the art manufacturing facility in Monroe in 2021, demonstrating our capability to offer high quality medicines with affordable access across multiple dosage platforms.”
Read the Cipla press release.
Read the Glenmark Pharmaceuticals press release.
