FDA Places New Andrx ANDAs on Hold

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ePT--the Electronic Newsletter of Pharmaceutical Technology

FDA Places All Andrx ANDAs on Hold

The Florida District office of the US Food and Drug Administration has placed a hold on all approvals for Andrx Corporation's (Fort Lauderdale, FL) abbreviated new drug applications (ANDAs) until the generic drug manufacturer can solve its manufacturing problems.

According to Andrx, FDA's action is attributed to a May 2005 inspection of its manufacturing facilities that resulted in an undisclosed list of inspectional observations (Form 483) and CGMP violations. Andrx says that it responded to these violations with a possible correction plan, but FDA never returned with a comment.

"Andrx is working to resolve the CGMP issues at its facility as quickly as possible," the company stated in a release. "The timing of that resolution is uncertain, and is not solely in our control."

The company said that it could be slapped with a bevy of sanctions including, "product recalls or seizures, fines, total or partial suspension of production and distribution, suspension of FDA's review of product applications, enforcement actions, injunctions and civil or criminal prosecution." Andrx's current product line is not affected at this time.

–George Koroneos