DifGen Pharmaceuticals LLC, a US-based specialty generic pharmaceutical company, announced on Thursday that its Canadian partner, Apotex Inc, has received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Nintedanib Soft Gel Capsules, 100 mg and 150 mg.

The product is therapeutically equivalent (AB-rated) to the reference listed drug, Ofev (nintedanib), which is indicated in adults for the treatment of idiopathic pulmonary fibrosis (IPF).

DifGen said that this approval represents a significant advancement in its expanding portfolio of complex generics.