Amarin Corp Plc (AMRN)

[rosemountbomber]

“If questions are raised about whether a generic drug performs the same as a brand-name product, we perform experiments in FDA laboratories, evaluate data and take a comprehensive scientific look at any possible differences between the products,” says Mansoor Khan, R.Ph., Ph.D., director of FDA’s Division of Product Quality Research.

In rare cases, new evidence emerges indicating that a generic drug may not have the safety or effectiveness as was previously believed. That’s what happened in 2012 with one of the generic forms of Wellbutrin XL 300 mg, a drug to treat depression. FDA sponsored a study comparing Budeprion XL 300 mg, the generic drug, with Wellbutrin XL 300 mg, and concluded that Budeprion XL 300 mg may not be as effective.”

https://www.fda.gov/consumers/consumer-updates/generic-drugs-undergo-rigorous-fda-scrutiny