Zydus gets tentative USFDA nod to generic Esomeprazole Magnesium delayed release capsules
Esomeprazole Magnesium reduces the amount of acid secreted by the stomach. The drug is used for the treatment of symptoms of gastroesophageal reflux disease and to reduce the risk of stomach ulcers in some people taking pain medicines, it added.
New Delhi: Drug firm Zydus Cadila Monday said it has received tentative approval from the US health regulator to market generic Esomeprazole Magnesium delayed-release capsules used for the treatment of acid reflux.
The product will be manufactured at the group's formulations manufacturing facility at a special economic zone in Ahmedabad, Zydus Cadila said in a statement.
Esomeprazole reduces the amount of acid secreted by the stomach. The drug is used for the treatment of symptoms of gastroesophageal reflux disease and to reduce the risk of stomach ulcers in some people taking pain medicines, it added.
The group now has 247 approvals and has, so far, filed over 330 abbreviated new drug applications (ANDAs) since the commencement of its filing process, Zydus Cadila said.
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