FDAnews Drug Daily Bulletin


Nov. 1, 2005

Andrx plans to meet with the FDA in November to discuss manufacturing issues that prompted the FDA to place the company's drug applications on hold.

In a recent letter to customers that was also filed with the Securities & Exchange Commission, the generic drugmaker said the FDA must re-inspect its plant before approving any pending applications.

"While we cannot predict the timing or outcome of the re-inspection, we are cautiously optimistic that the FDA will note the changes we have implemented so a resolution may be reached in the near term," Andrx's letter states. "We would emphasize that this status does not at this time affect our approved products or our ability to submit new generic drug applications."

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 then placed Andrx on OAI (Official Action Indicated) status. Consequently, all of Andrx's pending abbreviated new drug application were placed on hold, the company said in September.