Opioids For Pediatric Cough: UCB Seeks Limits, Pressuring Other Sponsors
UCB will make case for limiting use of Tussionex, its hydrocodone-containing antitussive, to patients 18 years and older at US FDA Pediatric Advisory Committee meeting, where panelists will consider the benefit/risk profile for all currently marketed opioid-containing cough treatments when used in children.
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Opioid Cough Restrictions: Pediatric Use, And Postmarket Studies, Likely Limited
US FDA advisory committee strongly recommends antitussives containing codeine or hydrocodone not be used by patients under age 18 years old, pointing to lack of modern evidence of benefit and known risks of respiratory depression and misuse. Expanding the contraindicated population could get some product sponsors off the hook for required pediatric studies.
Opioid Cough Medicines Might Face Complete Ban In Pediatric Patients
US FDA's Pediatric Advisory Committee sets meeting for meeting Sept. 11 to discuss the use of opioids with hydrocodone and codeine for treating pediatric cough.
Curtain Falls On Opana ER As Endo Agrees To US FDA Withdrawal Request
Company will cease manufacturing the extended-release oxymorphone formulation immediately and will not ship existing finished product after Sept. 1; decision to pull the opioid from the market heads off a fight with FDA, which sought withdrawal due intravenous abuse liability.