Zydus Lifesciences on Wednesday said it has received final approval from the U.S. health regulator to market its generic version of famotidine injection indicated to treat ulcers of the stomach and intestines.
The approval granted by the U.S. Food and Drug Administration (U.S.FDA) is for famotidine injection of strength 40 mg/4mL (10 mg/mL) and 200 mg/20 mL (10 mg/mL) multiple-dose vials, the company said in a regulatory filing.
Famotidine injection is indicated to treat ulcers of the stomach and intestines and to prevent intestinal ulcers from coming back after they have healed, it added.
It is also used to treat certain stomach and throat problems such as erosive esophagitis, gastroesophageal reflux disease (GERD) and Zollinger-Ellison syndrome, the company said.
The drug will be manufactured at the group’s injectable manufacturing facility at Jarod, near Vadodara in Gujarat, Zydus Lifesciences said.
The injection had annual sales of $1.9 million in the U.S., it said citing IQVIA MAT September 2022 data.
