FDAnews Drug Daily Bulletin

ANDRX TO MEET WITH FDA TO DISCUSS GMP PROBLEMS

Dec. 9, 2005
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Andrx will meet with the FDA on Dec. 14 to discuss manufacturing issues that have stalled the company's drug approvals, Andrx said in a recent filing with the Securities and Exchange Commission (SEC).

Andrx initially said it expected to meet with the FDA in late November, but the firm revealed in a recent SEC filing that the meeting was pushed back to this month.

Andrx requested the meeting after the FDA penalized the drugmaker for possible manufacturing violations discovered during a May inspection of Andrx's Florida manufacturing plant. The FDA initially issued Andrx a Form 483 documenting an undisclosed number of observations. The FDA's Florida District office then put Andrx on OAI (Official Action Indicated) status, placing all of the firm's pending abbreviated new drug applications on hold, the company said in September.

In an Oct. 18 letter to customers that was also filed with the SEC, Andrx said the FDA must re-inspect its plant before approving any pending applications, but that it was "cautiously optimistic" it would pass the facility review.