Indian cos in FDA's first list for generic Aciphex tablets

Dr Reddy's, Lupin and Torrent Pharma get nod from the US health regulator

In a decision that will cheer the domestic pharma industry, Indian firms, including Dr Reddy's, Lupin and Torrent Pharma, have received nod from the US health regulator to market the first generic version of Aciphex, used to treat gastroesophageal reflux disease (GERD).

 

First generic versions of Aciphex (rabeprazole sodium) delayed-release tablets, used to treat gastroesophageal reflux disease (GERD) in adults and adolescents (ages 12 and up) have been approved, US Food and Drug Administration said in a statement.

 

Dr Reddy's Laboratories Ltd, Lupin Pharmaceuticals Inc, Kremers Urban Pharmaceuticals Inc, Mylan Pharmaceuticals Inc, Teva Pharmaceuticals USA, and Torrent Pharmaceuticals Ltd have received FDA approval to market generic rabeprazole, it added.

 

The patent for Aciphex (rabeprazole sodium) was held by Eisai Inc.

 

"Health care professionals and consumers can be assured that FDA-approved generic drugs have met the same rigid standards of quality as the brand-name drug," Acting director of the Office of Generic Drugs in the FDA's Center for Drug Evaluation and Research Kathleen Uhl said.

 

This medication is widely used by people who have gastroesophageal reflux disease, so it is important to have access to affordable treatment options, she added.

 

Rabeprazole is in a class of medications called proton- pump inhibitors. The medication works by decreasing the amount of acid made in the stomach, treating the symptoms of GERD such as heartburn, regurgitation of acid, and nausea, FDA said.

 

It is also used to treat conditions in which the stomach produces too much acid, such as Zollinger-Ellison syndrome. In addition, rabeprazole is also used to treat ulcers, it added.

 

"Generic prescription drugs approved by the FDA have the same high quality and strength as brand-name drugs. Generic prescription drug manufacturing and packaging sites must pass the same quality standards as those of brand-name drugs," it added.