FDA panel will review drug-associated suicidality study
Executive Summary
FDA will discuss the results of its analysis of suicidality from placebo-controlled trials of 11 drugs at a joint advisory committee meeting, which could lead to broad class labeling changes. Members of the Peripheral and Central Nervous System Drugs, Psychopharmacological Drugs, Pediatric, and Drug Safety and Risk Management Advisory Committees will meet July 10 to consider the analysis and determine whether any additional actions are necessary. Findings of increased risk of suicidality in patients taking antiepileptic drugs were noted in a MedWatch alert issued in January (1"The Pink Sheet," Feb. 4, 2008, p. 3)
You may also be interested in...
Antiepileptics Show Risk Of Suicidality, May Cause Labeling Convulsions
FDA findings of an increased risk of suicidality in patients given antiepileptic drugs will likely lead to broad class labeling changes, according to a MedWatch alert issued Jan. 31
Japan Grants Global-First Approval To Zolbetuximab, 15 Other New Drugs
Astellas's first-in class CLDN18.2-targeting antibody receives its first approval worldwide, while crovalimab and a number of drugs for rare diseases also receive nods from regulators and are now awaiting reimbursement price-listing.
Hanmi-OCI Merger Hits Wall As Brothers Win Shareholder Vote, Board Seats
The planned merger of Korea's Hanmi Pharm Group with OCI Group hits a major speed bump as the two sons of Hanmi's founder and other candidates recommended by them secture board seats. But it remains to be seen how the Lim brothers will fulfil their ambitious promises.