Comments
Drug firm Natco Pharma has received final approval from the US health regulator for generic version of Budesonide capsules used for the 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 US 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 USD 370 Million for 12 months ending December 2015, according to IMS Health,” it added.
Shares of Natco Pharma ended the session up by 0.08 per cent at Rs 590.05 on the BSE.
Comments
Comments
Comments have to be in English, and in full sentences. They cannot be abusive or personal. Please abide by our community guidelines for posting your comments.
We have migrated to a new commenting platform. If you are already a registered user of TheHindu Businessline and logged in, you may continue to engage with our articles. If you do not have an account please register and login to post comments. Users can access their older comments by logging into their accounts on Vuukle.