Posted by Michael Wonder on 30 Jan 2018
FDA has to explain why Amgen was denied a key marketing incentive
30 January 2018 - Did the FDA treat Amgen differently than Johnson & Johnson when reviewing applications for their drugs?
A federal judge ruled late last week that the agency, in fact, may have acted inconsistently when it denied paediatric exclusivity for a blockbuster Amgen drug and ordered the FDA to explain its reasoning.
The ruling could mean that Amgen may eventually win six months of paediatric exclusivity, which would allow the company to forestall generic competition to a best-selling drug.
