FDA approves first rabeprazole generics for treatment of GERD / News / Generics / Home - GaBi Online

FDA approves first rabeprazole generics for treatment of GERD

Generics/News | Posted 29/11/2013 0 Post your comment

On 8 November 2013, the US Food and Drug Administration (FDA) announced that the agency had approved the first generics of Aciphex (rabeprazole) delayed-release tablets, used to treat gastroesophageal reflux disease (GERD) in adults and adolescents (ages 12 and up).

Rabeprazole is in a class of medications called proton pump inhibitors. Rabeprazole delayed-release tablets are the generic version of Eisai Corporation’s Aciphex tablets, and are indicated for short-term treatment in the healing and symptomatic relief of erosive or ulcerative GERD and for short-term treatment in the healing and symptomatic relief of duodenal ulcers. GERD, also called acid reflux or acid regurgitation, is a common condition in which backward flow of acid from the stomach causes heartburn and possible injury to the esophagus (the tube that connects the throat and stomach). Rabeprazole works by decreasing the amount of acid made in the stomach and is also used to treat conditions in which the stomach produces too much acid, such as Zollinger-Ellison syndrome.

Dr Reddy’s Laboratories, Kremers Urban Pharmaceuticals (part of UCB), Lupin Pharmaceuticals, Mylan Pharmaceuticals, Teva Pharmaceuticals USA and Torrent Pharmaceuticals have all received FDA approval of their abbreviated new drug applications (ANDAs), giving them the right to market generic rabeprazole in the US.

In the clinical trials for Aciphex in adults, the most common adverse reactions reported by those taking Aciphex were sore throat, flatulence, infection and constipation. In studies of adolescents, the adverse reactions most frequently reported by those taking Aciphex were abdominal pain, diarrhoea and headache.

Aciphex tablets, 20 mg, had US sales of approximately US$830 million for the 12 months ending 30 September 2013, according to IMS Health.

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Source: FDA, Mylan