New Delhi : Drug firm Natco Pharma has received final approval from the US health regulator for generic version of Budesonide capsules used for treatment of active Crohn’s disease for the American market.
The company has received “final approval of abbreviated new drug application (ANDA) from the US Food and Drug Administration (USFDA) for generic version of Budesonide capsules (enteric coated), 3 mg,” Natco Pharma said in a filing to BSE.
Entocort EC is indicated for the treatment of mild to moderate active Crohn’s disease involving the ileum and/or the ascending colon in patients 8 years of age and older.
NATCO and its marketing partner Alvogen, plan to launch the product in the USA market immediately, it added.
Perrigo Pharma International DAC sells Budesonide capsules under their brand Entocort in the US market, Natco Pharma said.
“Entocort EC capsules, 3 mg, and its generic versions had US sales of around $370 Million for 12 months ending December 2015, according to IMS Health,” it added.
Shares of Natco Pharma were today trading at Rs 593.05 per scrip in the afternoon trade on BSE, up 0.59 per cent from its previous close.