FDA awaits court move on Actavis Totowa

The US Food and Drug Administration announced that it had filed a Consent Decree on December 23, 2008, and currently awaits the court's  entry of a permanent injunction that bars Actavis Totowa, the US  manufacturing arm of Iceland-based generics group Actavis, Actavis Inc  and their officers, Sigurdur Oli Olafsson and Douglas Boothe, from  manufacturing and distributing drugs at the firm's Totowa, New Jersey,  facilities. The injunction will remain in effect until Actavis Totowa  comes into compliance with US current Good Manufacturing Practice  requirements, and obtains the FDA's approval to manufacture and  distribute drugs in the USA. The companies and their officers had also  allegedly been manufacturing and distributing unapproved drugs in  America.

The defendants signed a consent decree that permits them to resume  operations with respect to three categories of drugs only after an  expert certifies that they comply with the cGMP requirements and have  FDA approval, and the agency inspects to confirm compliance with the  law. The Consent Decree also requires the defendants to destroy any  remaining drugs which they recalled in April-July 2008 period, that are  currently in their possession.