FDA Denies Amneal Petition Seeking to Block Generic Versions of Osteoporosis Treatment
By Zachary Brennan -
Published 09 January 2018
Capping a string of recent citizen petition denials, the US Food and Drug Administration (FDA) has rejected Amneal Pharmaceuticals' citizen petition asking the agency to refrain from approving any abbreviated new drug applications (ANDAs) for the blockbuster osteoporosis treatment Forteo (teriparatide).
Categories: News, US, FDA, Biologics and biotechnology, Generic drugs, Government affairs, Regulatory intelligence, Regulatory strategy
Tags: Forteo, osteoporosis, Amneal, Lilly, citizen petitions