According to Lupin, the FDA has tentatively approved the company’s ANDA for revefenacin inhalation solution, a generic of Mylan’s Yupelri inhalation solution. Yupelri was approved by the FDA for the treatment of COPD in 2018.
Lupin currently sells a number of inhalation products in the US, including a generic of ProAir HFA albuterol MDI, a generic of Spiriva Handihaler tiotropium DPI, a generic of Perforomist formoterol fumarate inhalation solution, Brovana arformoterol inhalation solution, and a generic of Pulmicort Respules budesonide inhalation suspension.
Read the Lupin press release
