FUSION IV Pharmaceuticals, Inc dba AXIA Pharmaceutical is voluntarily recalling all unused sterile drug products to the user level as they do not adhere to federal guidelines.
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Supplemental new drug application (sNDA) has been approved for an expanded indication of MYCAMINE® for the treatment of invasive candidiasis in paediatric patients under four months old.
Alkermes, Inc. have received the warning letter after a promotional material review found it failed to adequately represent the risks of using the drug Vivitrol for patients with opioid use disorder.