Zydus Lifesciences bags final USFDA approval for Famotidine Injection

23 Nov 2022 , 02:58 PM

The United States Food and Drug Administration (USFDA) has given Zydus Lifesciences Limited (formerly Cadila Healthcare Limited) final approval to market Famotidine Injection USP, 40 mg/4 mL (10 mg/mL) and 200 mg/20 mL (10 mg/mL) multiple-dose vials.

Famotidine Injection is used to treat stomach and intestine ulcers, as well as to keep intestinal ulcers from returning after they have healed. This medication is also used to treat conditions affecting the stomach and throat (oesophagus), such as erosive esophagitis, gastroesophageal reflux disease (GERD), and Zollinger-Ellison syndrome.

According to IQVIA data, Famotidine Injection had annual sales of USD 1.9 million in the United States (IQVIA MAT Sep 2022). The drug will be produced at the group’s injectable manufacturing facility in Jarod, India, near Vadodara.

Since the beginning of the filing process in FY 2003-04, the group has received 333 approvals and has filed over 431 ANDAs.

At around 3.01 PM, Zydus Lifesciences was trading at Rs394.10 up by 0.42% from its previous closing of Rs392.45 on the BSE. The scrip touched intraday high and low of Rs395.30 and Rs390.85 respectively.

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