Exela’s Fentanyl Not Withdraw Over Safety/Efficacy

Federal Register notice: FDA has determined that Exela Pharma Sciences’ fentanyl citrate injections, equivalent to 2.5mg/50mL and 5mg/100mL (EQ 0.05 mg base/mL), were not withdrawn from sale due to safety or effectiveness reasons. The determination permits the agency to approve ANDAs that reference the products if all other legal and regulatory requirements are met. The drug is indicated in adult and pediatric patients ages two years and older for use as an opioid analgesic supplement in general anesthesia, for administration with a neuroleptic for the induction of anesthesia and as an adjunct in the maintenance of general anesthesia, and for use as an anesthetic agent with oxygen in selected high-risk patients, such as those undergoing open heart surgery or certain complicated neurological or orthopedic procedures. To view the notice, click here.