Court Grants Summary Judgment Favoring Mylan & FDA Regarding Generic Precedex

(RTTNews) - Generic drugmaker Mylan Inc. (MYL) commented on a ruling by the U.S. District Court for the District of Maryland pertaining to its product, Dexmedetomidine Hydrochloride Injection, 100 mcg (base)/mL, packaged in 200 mcg (base)/2 mL Single-dose Vials, that was approved by the U.S. Food and Drug Administration or FDA as therapeutically equivalent to Hospira Inc.'s Precedex.

On September 5, the Court granted summary judgment favoring Mylan, Par Sterile Products and FDA, and lifted a previously entered temporary restraining order against those parties related to generic Precedex. As a result of the ruling, Mylan is free to immediately resume distribution of its generic Precedex to customers.