Search Results for osteoporosis

Showing 1 – 4

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

FDA Issues New Guidance on Osteoporosis Drug Development By Michael Mezher - Published 13 June 2016

The US Food and Drug Administration (FDA) on Monday issued new draft guidance calling for drugmakers to conduct long-term nonclinical bone quality studies for osteoporosis treatments.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Preclinical, Regulatory strategy

Tags: Osteoporosis, Animal studies, Bone quality

Revisions to Osteoporosis Guideline Called for by EMA By Alexander Gaffney, RF News Editor - Published 01 November 2012

Categories: EMA

Tags: GIOP, Osteoporosis, Concept Paper, guideline

EMA Issues Warning on Osteoporosis Medicines By Alexander Gaffney - Published 23 July 2012

Categories: EMA

Tags: Use, Osteoporosis, Bone, Latest News, cancer, safety