Actavis Announces FDA Warning Letter following FDA Inspection
Reykjavik, Iceland, 14 September 2006 - Actavis Group (ICEX: ACT), the international generic pharmaceuticals company, announced today that it has received a warning letter from the U.S. Food and Drug Administration (FDA), related to its inspection of the Group’s solid oral dose manufacturing facility in Little Falls, New Jersey.
The Warning Letter identifies deficiencies in the way that Actavis has handled its adverse medical event reporting obligations. The Warning Letter also questions the marketing status of certain of Actavis’s older products that are currently being marketed by the Group relying on pre-ANDA drug approval mechanisms (“Older Drugs”). Since the inspection, Actavis has materially revised its adverse drug event and pharmacovigilence procedures to address certain deficiencies and to establish a system that ensures continuous compliance with regulatory expectations. The Group has also complied with all previous adverse medical event-reporting obligations that were over due or deficient. Management is confident that each of the identified Older Drugs are currently being marketed in accordance with applicable regulations, but is undertaking a full review of these products to address the FDA’s concerns.
Actavis has already submitted to the FDA a comprehensive response to the Warning Letter. 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.
About Actavis Group
Celebrating its 50th anniversary this year, Actavis is one of the world’s leading generic pharmaceutical companies specializing in the development, manufacture and sale of generic pharmaceuticals. Based in Iceland, the company has operations in over 30 countries, with over 10,000 employees. The company’s market cap is approximately EUR2.3bn (US$3 billion) and it’s listed in the Iceland Stock Exchange. Actavis expects 2006 sales to total EUR1.4bn, with approximately one-third of these sales coming from the United States, the company’s single largest market. In the US alone, the company expects to launch 15 new products in 2006, in addition to filing 30 ANDAs. The company’s US operations are located in New Jersey, Maryland and North Carolina.
More information about Actavis can be found at www.actavis.com.
- Contact Information
- Halldor Kristmannsson
- Vice President of Corporate Communications
- Contact via E-mail
This news content was configured by WebWire editorial staff. Linking is permitted.
News Release Distribution and Press Release Distribution Services Provided by WebWire.