Natco receives US FDA approval for generic budesonide capsule

Natco Pharma Limited on Thursday announced that it has received final approval from the US Food and Drug Administration (FDA) for generic version of budesonide capsule (enteric coated) 3 mg. Natco and its marketing partner Alvogen plan to launch this product in the US immediately.

The approved product is the generic version of Perrigo Pharma’s Entocort EC capsule. According to IMS Health, Entocort EC capsule (3 mg) and its generic versions had US sales of approximately $ 370 million for twelve months ending December 2015.

Entocort is a gastroenterology medicine used for treating patients with mild to moderate Crohn's disease.