Andrx ( ADRX) says it plans to meet with the Food and Drug Administration in November to resolve manufacturing issues that have prompted the agency to withhold acting on drug applications until the problems are fixed. In a letter to customers, the Fort Lauderdale, Fla., maker of generic drugs said the FDA must re-inspect the plant in Davie, Fla., before lifting the hold on drug-application approvals. "While we cannot predict the timing or outcome of the re-inspection, we are cautiously optimistic" that the FDA will acknowledge the improvements in Andrx's manufacturing practices, the Oct. 18 letter to customers indicated. The letter was made public Wednesday in a document filed with the Securities and Exchange Commission. "We would emphasize that this status does not at this time affect our approved products or our ability to submit new generic drug applications," the letter continues. "The FDA continues to review our approximately 30
applications and, as recently as last week, the FDA advised us that another of our products is ready for approval pending resolution of the agency's inspection observations." The letter came from Thomas P. Rice, Andrx's CEO, and Larry Rosenthal, president of the company's generic-drug unit. Rice and Rosenthal told customers that Andrx remains "in robust financial health" with no outstanding long-term debt and $345 million in cash and investments. Andrx alerted investors last month to the dispute involving an FDA inspection in May of the Davie plant. The agency stepped up the pressure, alleging that Andrx hadn't acted quickly enough to fix the problems. At the time, Andrx said it had filed a detailed response to the FDA's complaint, including plans for correcting the problems. Shares of Andrx were down 7 cents at $15.07.