US FDA nod for desi version of Aciphex

Published: 11th November 2013 06:00 AM  |   Last Updated: 11th November 2013 12:43 AM   |  A+A-

Indian pharma firms like Dr Reddy's Laboratories Ltd, Lupin Pharmaceuticals Ltd and Torrent Pharma have received nod from the US Food and Drug Administration (FDA) to market the first generic version of Aciphex, used to treat gastroesophageal reflux disease (GERD).

This comes at a time when several domestic pharma companies are being pulled up by US the health regulator for alleged violation of good manufacturing norms.

DRL, Lupin, Kremers Urban Pharmaceuticals Inc, Mylan Pharmaceuticals Inc, Teva Pharmaceuticals USA and Torrent Pharmaceuticals Ltd have received FDA approval to market generic rabeprazole, the FDA said in a statement.

The patent for Aciphex (rabeprazole sodium) was held by Risai Inc and is widely used by people who have gastroesophageal reflux disease.

“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,” said Kathleen Uhl, Acting Director of the Office of Generic Drugs, FDA's Centre for Drug Evaluation and Research adding, “It is important to have access to affordable treatment options.”

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 said.

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