FDAnews Drug Daily Bulletin


Nov. 17, 2005

Andrx plans to meet with the FDA around Thanksgiving to discuss manufacturing violations that have stalled approval of its drug applications. The company, which requested the meeting, said the FDA has not yet commented on any of its responses to the inspectional observations.

During its recent third-quarter conference call, Andrx executives did not reveal the specific products that may have been improperly manufactured, but did say that the drugs involved are "historical products."

During a May inspection, the FDA discovered possible current good manufacturing practice violations at Andrx's operations in Florida. At the close of the inspection, the FDA investigator issued Andrx a Form 483 documenting an undisclosed number of observations. The agency's Florida District office later placed Andrx on OAI (Official Action Indicated) status, which placed all of the firm's pending abbreviated new drug applications (ANDA) on hold.

The manufacturing problems have also affected Andrx's 505(b)(2) new drug application (NDA) for a valproate sodium product, which the company wants to market as a treatment for various neurological disorders, such as bipolar disorder, seizure disorders and migraines.

"In May 2004, FDA issued a tentative NDA approval for our valproate sodium product. Final approval is pending our removal from OAI status, FDA's response to the Citizen Petition filed by Abbott Laboratories and/or favorable resolution of the patent infringement litigation filed by Abbott Laboratories," Andrx said in its third-quarter SEC filing.
Abbott Laboratories sued Andrx in 2003, claiming that Andrx's NDA for valproate is too similar to Abbott's neurological disorder drug Depakote (divalproex sodium).

Depakote, which had sales of more than $700 million so far this year, would compete in the same market as Andrx's product. Andrx is awaiting the court's decision on a request for summary judgment in the case; a trial is scheduled for February 2006.