"The FDA wants to assure consumers who rely on these products for pain relief that they will still have access to FDA-approved narcotic drugs and there will be no shortage for consumers," Autor told reporters.
Starting in late March, the companies had 60 days to stop manufacturing these products and 90 days to stop distributing them, Autor added. "FDA expects all manufacturers and distributors of unapproved versions of these products to honor these deadlines and will not tolerate any manufacture or distribution after these deadlines," she said.
The companies getting warning letters were: Boehringer Ingelheim Roxane Inc., of Columbus, Ohio; Cody Laboratories Inc., Cody, Wyo.; Glenmark Pharmaceuticals Inc., Mahwah, N.J.; Lannett Co., Philadelphia; Lehigh Valley Technologies Inc., Allentown, Pa.; Mallinckrodt Inc. Pharmaceuticals Group, St. Louis; Physicians Total Care Inc., Tulsa, Okla.; Roxane Laboratories Inc., Columbus, Ohio; and Xanodyne Pharmaceuticals Inc., Newport, Ky.
Throckmorton said Thursday that the stop-order for the other painkillers was still in place.
For more on unapproved drugs, visit the U.S. Food and Drug Administration.
SOURCES: Associated Press; March 31, 2009, teleconference with Deborah Autor, J.D., director, Office of Compliance, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Rockville, Md.
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