Nine companies are asked to stop making unapproved narcotics.The Food and Drug Administration has warned nine companies to stop manufacturing and marketing 14 narcotic products, including unapproved un·ap·proved
Not approved or sanctioned: an unapproved vaccine; an unapproved protest march. versions of high-concentrate morphine sulfate oral solution and unapproved immediate-release tablets containing morphine sulfate, hydromorphone, or oxycodone oxycodone /oxy·co·done/ (-ko´don) an opioid analgesic derived from morphine; used in the form of the hydrochloride and terephthalate salts.
n. , Deborah Autor, of the FDA's Center for Drug Evaluation and Research The Center for Drug Evaluation and Research is a division of the FDA that deals with the approval of drugs. CDER reviews New Drug Applications to ensure that the drugs are safe and effective. It is one of five Centers at the United States Food and Drug Administration. , said in a press briefing.
These warnings are the FDA's latest efforts in an ongoing fight against the production and sale of unapproved drugs in the United States, Ms. Autor said.
The nine companies that received the warnings are Glenmark Generics Inc., Lannett Co., Lehigh Valley Technologies Inc., Mallinckrodt Inc. Pharmaceuticals Group, Xanodyne Pharmaceuticals Inc., Physicians Total Care Inc., Roxane Laboratories Inc., Boehringer Ingelheim Roxane Inc., and Cody Laboratories Inc.
"This action does not affect FDA-approved versions of these drugs," she said, adding that the action would affect consumers who use narcotics for pain relief, but she emphasized that there is an adequate supply of FDA-approved products to meet consumers' needs.
The companies that receive FDA warnings have 60 days to stop manufacturing their unapproved narcotics and 90 days to stop distributing them. Failure to comply with the FDA's request could result in the seizure of the unapproved drugs, Ms. Autor said.
The FDA is encouraging companies to apply for approval and is conducting outreach to let doctors and pharmacists know that there are many unapproved drugs on the market that "may not be safe, effective, adequately labeled, or of good quality," Ms. Autor said.
"Doctors [need to] know that these products are being removed from the market," Dr. Charles Lee, a medical officer at CDER CDER Center for Drug Evaluation and Research (US FDA)
CDER Centre de Développement des Energies Renouvelables (French)
CDER Client Development and Evaluation Report , said in a question-and-answer session. But they also should know there are FDA-approved alternatives for them to supply needs of their patients, he said.