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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The FDA's Oncologic Drugs Advisory Committee will consider whether appropriate dosages of belantamab mafodotin have been identified for two second-line, multiple myeloma indications. Ocular toxicities and large number of dose modifications in trials raised FDA concerns about benefit-risk.
The official separation of those impacted by the reduction-in-force and some others who are leaving the agency are not yet reflected in CDER employee gains and losses data.