US approval of generic Protonix for Actavis and Risperdal for Taro; Watson does not infringe patent

10 February 2011

Iceland headquartered Actavis says that it has received approval from the US Food and Drug Administration to market the gastro-intestinal drug pantoprazole sodium delayed-release tablets, USP. Distribution of the product will commence shortly.

Pantoprazole 20mg and 40mg, the generic equivalent of Protonix 20mg and 40mg by Pfizer, had US sales of around  $1.6 billion for the 12 months ending December 31, 2010, according to IMS Health.

The FDA also approved a generic version of Johnson & Johnson (NYSE: JNJ) subsidiary Janssen -Cilag’s atypical antipsychotic Risperdal (risperidone) oral solution for the US unit of Indian drugmaker Taro Pharmaceuticals.

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