Natco Pharma Limited has gained final approval of Abbreviated New Drug Application (ANDA) from the U.S. Food and Drug Administration (FDA) for generic version of Budesonide Capsules (Enteric Coated), 3 mg .
Natco with its marketing partner Alvogen plans to launch this product in the USA market immediately.
Perrigo Pharma International DAC sells Budesonide Capsules under their brand
Entocort in the USA market. Entocort EC Capsules, 3 mg, and its generic
versions had U.S. sales of approximately $370 Million for twelve months ending
December 2015, according to IMS Health.