US FDA Investigating Auto-Injector Problems With Copaxone Generics
Reports of bent needles and injector failures also raise questions about the FDA’s complex product approval process.
You may also be interested in...
US FDA told the company to add a warning to the label in late January, about a month before the generic refill cartridge was approved.
The US FDA commissioner called for enhancements to postmarketing data collection and analysis for generic drugs.
Boehringer Ingelheim Wins Interchangeable Biosimilar To Humira, Setting Benchmark For Switching Studies
Cyltezo won’t be available until 2023 due to patent settlement with AbbVie. The second-ever interchangeable biosimilar approved by the US FDA also contains a first: published data from a switch trial.