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news.Icelandic generic pharmaceuticals company Actavis said that it has received a warning letter from the FDA relating to the company's solid oral dose manufacturing facility in New Jersey, US.
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The letter relates to deficiencies in the way that Actavis has handled its adverse medical event reporting obligations and also questions the marketing status of certain of Actavis’s older products. Since the inspection Actavis has taken steps to address the concerns, the firm added.
Actavis said in a statement: “The group is confident that based on the actions it has taken to date and its willingness to undertake any additional actions that may be required, it will fully address the concerns of the FDA.
“Furthermore, the group does not anticipate launching new products from the plant until it has resolved all outstanding compliance issues to the satisfaction of the FDA. This is not expected to result in a material impact on 2006 financial results or the group’s guidance on growth and margins in 2007.”
Actavis is currently involved in a takeover battle with Barr Pharmaceuticals for Pliva, the Croatian pharmaceuticals firm. Whichever company wins will become the world’s third-largest generic drugmaker behind Israel’s Teva Pharmaceutical Industries and Novartis of Switzerland.