USFDA nod to Zydus Lifesciences Famotidine Injection
Famotidine Injection is indicated to treat ulcers of the stomach and intestines and to prevent intestinal ulcers from coming back after they have healed.
Ahmedabad: Zydus Lifesciences Limited (formerly known as Cadila Healthcare Limited) has announced that the company has received final approval from the United States Food and Drug Administration (USFDA) to market Famotidine Injection USP, 40 mg/4 mL (10 mg/mL) and 200 mg/20 mL (10 mg/mL) multiple-dose vials (USRLD: Pepcid injection).
Famotidine Injection is indicated to treat ulcers of the stomach and intestines and to prevent intestinal ulcers from coming back after they have healed. This medication is also used to treat certain stomach and throat (esophagus) problems such as erosive esophagitis, gastroesophageal reflux disease-GERD, and Zollinger-Ellison syndrome.
Famotidine Injection had annual sales of USD 1.9 mn in the United States according to IQVIA data (IQVIA MAT Sep 2022). The drug will be manufactured at the group's injectable manufacturing facility at Jarod, near Vadodara, India.
The group now has 333 approvals and has so far filed over 431* ANDAs since the commencement of the filing process in FY 2003-04.
Zydus Lifesciences Limited, formerly known as Cadila Healthcare Limited, is an Indian multinational pharmaceutical company headquartered in Ahmedabad. The company is primarily engaged in the manufacture of generic drugs. Zydus group has manufacturing sites and research facilities spread across five states of Gujarat, Maharashtra, Goa, Himachal Pradesh, and Sikkim in India and in the US and Brazil.
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