News
9 Sep 2014
Court Grants Summary Judgment in Favour of Mylan and FDA Related to Generic Precedex
Mylan Inc. has commented on a ruling by the US 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 FDA as therapeutically equivalent to Hospira Inc.'s Precedex.
On 5 September, the Court granted summary judgment in favour of 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.
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