AstraZeneca discontinues Elavil
Executive Summary
AstraZeneca has discontinued its antidepressant Elavil (amitriptyline). The injection form is no longer available and the tablet inventory is expected to be depleted by the end of the year. The drug, which was manufactured by Merck, was cited for GMP problems in 2000 (1"The Pink Sheet" July 17, 2000, p. 24)...
You may also be interested in...
Vioxx GMP Violations Cited In FDA Warning Letter Spur Merck Retraining
Inadequate sampling, testing, investigation and documentation of Merck's Vioxx (rofecoxib) lots are among good manufacturing practice violations cited in a June 27 FDA warning letter.
Recent And Upcoming FDA Advisory Committee Meetings
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
OIG: FDA’s EUA Approach Allowed Bad Tests To Reach Market
A review by a government watchdog found the FDA’s review process for COVID-19 diagnostics was plagued by issues including allowing low-quality tests to slip through, high reviewer workloads, and manufacturer frustration.