Astellas Pharma Inc. announced that the U.S. Food and Drug Administration (FDA) accepted priority review for its New Drug Application (NDA) for mirabegron for oral suspension and its supplemental New Drug Application (sNDA) for Myrbetriq® (mirabegron) tablets for the treatment of neurogenic detrusor overactivity (NDO) in pediatric patients aged three years and older. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is March 28, 2021. NDO is a neurological bladder dysfunction caused by nerve damage. Children with NDO may experience involuntary bladder contractions, which can lead to symptoms of urinary urgency, frequency and incontinence. Spina bifida, a congenital spinal cord defect, is a common cause of NDO in children. The NDA and sNDA were based on findings from a Phase 3 pivotal study that evaluated the efficacy, safety, tolerability and pharmacokinetics of mirabegron in children and adolescents (aged 3 to <18 years) with NDO and using clean intermittent catheterization (ClinicalTrials.gov Identifier: NCT02751931). Myrbetriq® tablets were initially approved in 2012 in the United States for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency and urinary frequency. Myrbetriq is not for everyone. Do not take Myrbetriq if they have an allergy to mirabegron or any ingredients in Myrbetriq. Myrbetriq may cause their blood pressure to increase or make their blood pressure worse if they have a history of high blood pressure. It is recommended that their doctor check their blood pressure while they are taking Myrbetriq. Myrbetriq may increase their chances of not being able to empty their bladder. Tell their doctor right away if they have trouble emptying their bladder or they have a weak urine stream. Myrbetriq may cause allergic reactions that may be serious. If they experience swelling of the face, lips, throat or tongue, with or without difficulty breathing, stop taking Myrbetriq and tell their doctor right away. Tell their doctor about all the medicines they take including medications for overactive bladder or other medicines such as thioridazine (Mellaril™ and Mellaril-S™), flecainide (Tambocor®), propafenone (Rythmol®), digoxin (Lanoxin®), or solifenacin succinate (VESIcare®). Myrbetriq may affect the way other medicines work, and other medicines may affect how Myrbetriq works. Before taking Myrbetriq, tell their doctor if they have liver or kidney problems. The most common side effects of Myrbetriq include increased blood pressure, common cold symptoms (nasopharyngitis), dry mouth, flu symptoms, urinary tract infection, back pain, dizziness, joint pain, headache, constipation, sinus irritation, and inflammation of the bladder (cystitis). The most common side effects of MYRBETRIQ, when used with solifenacin succinate, include dry mouth, urinary tract infection, constipation, and fast heartbeat.