According to Indian generics developer Alembic Pharmaceuticals, the company’s ANDA for a generic version of Sunovion’s Brovana arformoterol tartrate inhalation solution for the treatment of COPD has received final FDA approval. Alembic co-developed the arformoterol inhalation solution with Indian CRO Orbicular Pharmaceutical Technologies.
The ANDA approval is Alembic’s second for an inhalation product. In November 2021, the company announced that the FDA had approved its generic of Mylan’s Perforomist formoterol fumarate inhalation solution, which was also co-developed with Orbicular Pharmaceutical Technologies.
Over the past year, the FDA has fully approved a number of generics of Brovana, including versions from Cipla, Glenmark, and Lupin.
Read the Alembic Pharmaceuticals press release.
