The U.S. Food and Drug Administration (FDA) has sent warning letters to nine drug companies to stop manufacturing 14 unapproved narcotic drugs, as part of the FDA's initiative to crackdown on unapproved-drugs.
The warning letters notified the companies they may be subject to legal action if they do not stop manufacturing and distributing "unapproved narcotic prescription products" that include high concentrate morphine sulfate oral solutions and immediate release tablets containing morphine sulfate, hydromorphone or oxycodone. Oxycodone capsules are not included in this action.
The agency has no way of knowing whether these drugs are safe, if they contain labeled ingredients, or if they carry correct dosages, says Deborah M. Autor, J.D., FDA's Center for Drug Evaluation and Research (CDER).
The FDA began its unapproved-drug crackdown in June 2006. Since that time, 200 firms and 900 drug products have been subject to FDA actions.
According to the FDA, an estimated 2 percent of prescriptions in the United States are filled with unapproved drugs.
The firms subject to today's FDA warning letters are:
Boehringer Ingelheim Roxane, Inc., Columbus, Ohio; Cody Laboratories, Inc., Cody, Wyoming; Glenmark Pharmaceuticals Inc., Mahwah, N.J.; Lannett Company, Inc., 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.
Copies of the warning letters can be found on the FDA Web site.
Those people who rely on narcotics for pain relief will continue to have access to FDA-approved narcotic products that have been evaluated and determined to be safe and effective.
While there is no specific safety concerns, says Autor, lack of assurance of purity and quality raises concerns. These manufacturers have failed to submit data to the FDA that guarantees the safety and purity of their products.”
Firms have 15 days to reply to the warning. Manufacturers have 60 days to stop making these drugs and 90 days to stop shipping existing products. #