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Pediatric Acetaminophen Expanded Dosing Requested In McNeil Petition
Expanded dosing directions in the labeling of pediatric acetaminophen products to include children under two is requested by McNeil Consumer Healthcare in a citizen petition filed with FDA Feb. 1.
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
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Ensitrelvir, Shionogi's treatment for COVID-19, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
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AbbVie didn’t get everything it sought from a citizen petition but may still have the upper hand over smaller rivals after FDA gives makers of animal-derived thyroid medications a year to seek approval. If the agency removes compounded products, it could face more pricing pushback.
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The findings are consistent with some other research and likely are due to obesity patients becoming more connected to needed health care services.