Drugmaker Granules India has acquired U.S. Food and Drug Administration approval for Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg and 40 mg, a generic model of AstraZeneca Pharmaceuticals Nexium Delayed-Release Capsules.
Bioequivalent and therapeutically equal to reference listed drug Nexium Delayed-Release Capsules, 20 mg and 40 mg, of AstraZeneca Pharmaceuticals LP, Esomeprazole Magnesium capsules are indicated for short-term therapy of heartburn and different signs related to gastroesophageal reflux illness (GERD).
The present annual U.S. market for Esomeprazole Magnesium Delayed-Release Capsules is round $168 Million, Granules stated, citing MAT Jul 2023 IQVIA/IMS Health numbers, in a launch on U.S. FDA approving its abbreviated new drug software (ANDA). The firm stated it now has 62 ANDA approvals from the U.S. FDA (60 ultimate and a pair of tentative approvals).
Esomeprazole Magnesium capsules are additionally indicated for discount of nonsteroidal anti-inflammatory medicine (NSAID)-associated gastric ulcer in adults in addition to for long-term therapy of pathological hypersecretory situations, together with Zollinger-Ellison syndrome.
