FDAnews Drug Daily Bulletin


Dec. 27, 2005

The FDA plans to re-inspect Andrx's manufacturing facility to resolve good manufacturing practice (GMP) concerns, but did not indicate when it would conduct the inspection, Andrx said in a recent SEC filing.

Andrx will not be able to receive FDA approval for any of its pending drug applications until the agency determines the company has resolved the manufacturing issues. "As the company anticipated, the FDA will be conducting an inspection to evaluate the company's actions. The FDA did not comment on the timing of such inspection," Andrx said in the filing.

Andrx and the FDA met recently to discuss potential manufacturing violations discovered during a May inspection of Andrx's Florida manufacturing plant. The FDA subsequently issued Andrx a Form 483, and the agency's Florida District office then put Andrx on Official Action Indicated status, placing all of the firm's pending drug applications on hold.

Andrx currently has 30 abbreviated new drug applications and one new drug application pending with the FDA, according to its latest quarterly report. At the meeting, Andrx presented its responses to the FDA's Form 483 observations, as well as what actions the company has taken to maintain and improve its manufacturing and quality operations, Andrx said.

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.