WASHINGTON, May 28 (Reuters) - New opioid painkiller drugs could be approved before U.S. regulators impose stronger risk management plans for a broad group of the medicines, a U.S. health official said on Thursday.
'We do feel that we have a path forward that would allow the possibility for new products in this class to be approved before' the new safety plans are finalized, said Dr. John Jenkins, director of the Food and Drug Administration's Office of New Drugs.
Jenkins, speaking to reporters, said he could not comment on the status of any specific applications under review.
King Pharmaceuticals Inc is seeking approval for two experimental long-acting painkillers, Remoxy and Embeda.
The FDA announced in February it wanted manufacturers to take stronger measures on to prevent misuse and abuse of long-acting and sustained-release opioids, a class of powerful, highly addictive narcotics prescribed to relieve chronic pain.
(Reporting by Lisa Richwine; Editing by Steve Orlofsky) Keywords: PAINKILLERS/FDA (lisa.richwine@thomsonreuters.com; +1 202 310-5691; Reuters Messaging: lisa.richwine.reuters.com@reuters.net) COPYRIGHT Copyright Thomson Reuters 2009. All rights reserved. The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.
'We do feel that we have a path forward that would allow the possibility for new products in this class to be approved before' the new safety plans are finalized, said Dr. John Jenkins, director of the Food and Drug Administration's Office of New Drugs.
Jenkins, speaking to reporters, said he could not comment on the status of any specific applications under review.
King Pharmaceuticals Inc is seeking approval for two experimental long-acting painkillers, Remoxy and Embeda.
The FDA announced in February it wanted manufacturers to take stronger measures on to prevent misuse and abuse of long-acting and sustained-release opioids, a class of powerful, highly addictive narcotics prescribed to relieve chronic pain.
(Reporting by Lisa Richwine; Editing by Steve Orlofsky) Keywords: PAINKILLERS/FDA (lisa.richwine@thomsonreuters.com; +1 202 310-5691; Reuters Messaging: lisa.richwine.reuters.com@reuters.net) COPYRIGHT Copyright Thomson Reuters 2009. All rights reserved. The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.