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The FDA has granted a priority review for Purdue’s abbreviated new drug application for nalmefene prefilled syringes for complete or partial reversal of opioid overdose.
Maryland-based Medcura announced that the FDA has granted the company’s LifeGel absorbable surgical hemostatic gel Breakthrough Device designation as a hemostatic agent to control bleeding during surgical procedures.
Previous treatment options adapted surgical devices developed for adults and this is the first device specifically cleared by the FDA for pediatric use, the company said.