Actavis reintroduces oxycodone tablets to pharmacies

MORRISTOWN, N.J. Generic drug maker Actavis has reintroduced oxycodone tablets following an injunction last year by the Food and Drug Administration.

The company announced last week that its Actavis Totowa subsidiary had reintroduced oxycodone 15-mg and 30-mg tablets to pharmacies. The tablets are the first to be manufactured at its Little Falls, N.J., factory since a recently completed FDA inspection.

In December 2008, Actavis announced that it had reached agreement on a consent decree of permanent injunction with the FDA regarding the Actavis Totwa subsidiary, agreeing not to distribute any products from the Actavis Totowa plants until it proved that it met requirements demonstrating compliance with the FDA’s current good manufacturing practice requirements and passed follow-up FDA inspections.

“Through an extensive process, Actavis requalified all equipment and utilities for production and packaging, and we requalified and revalidated all methods used to release products from our Totowa facilities,” Actavis VP quality compliance and technical services Nasrat Hakim stated. “This is a very positive step and took incredible teamwork."