Mylan Inc. commented on a ruling by the U.S. District Court for the District of Maryland related to its product, dexmedetomidine hydrochloride injection, 100 mcg (base)/mL, packaged in 200 mcg (base)/2-mL single-dose vials, which was approved by the US Food and Drug Administration (FDA) as therapeutically equivalent to Hospira Inc.’s Precedex.

On September, 2014, the court granted summary judgment in favor of Mylan, Par Sterile Products (a business unit of Par Pharmaceutical), and the US Food and Drug Administration (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.

Par Pharmaceutical also announced that it has resumed shipping dexmedetomidine hydrochloride (HCl) injection, EQ 100 mcg base/mL following the lifting of the temporary restraining order by the federal district court. Last month, Par received final approval from the FDA for its abbreviated new drug application for dexmedetomidine HCl injection, which is indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures.

Par's dexmedetomidine HCl injection is packaged in 200 mcg/2 mL single-use vials (preservative free). US sales of Precedex Injection are approximately $156 million, according to IMS Health data, and as reported by Par.  

Source: Mylan and Par Pharmaceutical