Tag Archive for: acclerated approvals

AbbVie Inc. nd partner Johnson & Johnson intend to voluntarily withdraw the accelerated approvals of their Imbruvica drug in the U.S. for patients with certain types of blood cancer, the companies said on Thursday.

The FDA’s Center for Drug Evaluation and Research issued its briefing documents arguing for the market withdrawal of Covis Pharma’s Makena. The agency will discuss the drug on Oct. 17-19.