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.
At least one sponsor is getting ahead of possible new FDA restrictions on use of opioid-containing antitussants to treat pediatric cough.
If FDA agrees with UCB SA's request to contraindicate its Tussionnex (hydrocodone/chlorpheniramine) for patients under 18 years of age,...
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The FDA could act on 17 applications, including 10 novel agents, during August. Only one would be a second-cycle review.
Replimune's RP1 oncolytic immunotherapy became the third regenerative medicine to receive an FDA complete response letter this month as the agency appears to re-visit previous agreements about accelerated approval.
The 43 novel agents with user fee goal dates in the remainder of 2025 have fewer oncologics and infectious disease drugs than the first half of the year.
US FDA's 25 novel approvals in 2025 fell short of the agency's five-year average count, driven by a drop in drugs center approvals; 45 user fee goals remain in second half of year.
The 43 novel agents with user fee goal dates in the remainder of 2025 have fewer oncologics and infectious disease drugs than the first half of the year.
US FDA's 25 novel approvals in 2025 fell short of the agency's five-year average count, driven by a drop in drugs center approvals; 45 user fee goals remain in second half of year.
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