Court rules in favor of Mylan's generic Precedex

PITTSBURGH — Mylan is now free to resume distribution of its generic Precedex product (dexmedetomidine hydrochloride injection) to customers, effective immediately. 

 

The U.S. District Court for the District of Maryland granted summary judgment in favor of the company, Par Sterile Products, and the Food and Drug Administration. The court also lifted a temporary restraining order related to the generic. The drug received FDA approval in August.