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Natco Pharma has got the US health regulator’s approval for generic version of Budesonide capsules that are used for treatment of active Crohn’s disease for the American market.
Natco Pharma has said in a statement that 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.”
Entocort EC is indicated to treat mild to moderate active Crohn’s disease involving the ileum and/or the ascending colon in patient 8 years of age and older.
NATCO with its marketing partner Alvogen is planning to launch the product in the USA market immediately.
