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news.Par Pharmaceutical Companies has resumed shipping dexmedetomidine hydrochloride (HCl) injection, EQ 100 mcg base/mL, the generic version of Hospira's Precedex Injection. Par immediately resumed shipping after a US District Court lifted a temporary restraining order that was issued in August at Hospira's request.
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Last month, Par received final approval from the U.S. Food and Drug Administration 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). According to IMS Health data, annual U.S. sales of Precedex® Injection are approximately $156 million.
Due to the known pharmacological effects of dexmedetomidine HCl, patients should be closely monitored while receiving dexmedetomidine HCl. Use of dexmedetomidine has been associated with serious adverse reactions such as hypotension, bradycardia, sinus arrest and transient hypertension.
For further details of the Warnings and Precautions related to the use of dexmedetomidine HCl injection, please refer to the full prescribing information.
Safety and efficacy have not been established for Procedural Sedation in pediatric patients. Additional information describing clinical studies in a different indication in which efficacy was not demonstrated in pediatric patients is approved for Hospira’s dexmedetomidine injection.
However, due to Hospira’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. The use of dexmedetomidine HCl for procedural sedation in pediatric patients has not been evaluated.