FDA's March 25 "not approvable" letter for Forest's Lexapro (escitalopram) social anxiety disorder sNDA questions the reliability of data from a single study center, the company says. Excluding the problem center from efficacy analyses yields a non-statistically significant p-value of 0.06, "which the FDA no longer accepted as a positive pivotal study," Forest says. The decision closely follows FDA's second "not approvable" letter for use of the Celexa (citalopram) follow-on in panic disorder (1Pharmaceutical Approvals Monthly March 2005, In Brief)...
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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.’
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.
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.
The findings are consistent with some other research and likely are due to obesity patients becoming more connected to needed health care services.
