Shots:

• The US FDA has accepted the PR for NDA of mirabegron (oral suspension) and sNDA for Myrbetriq (mirabegron- tablets) for neurogenic detrusor overactivity (NDO) in pediatric patients aged ≥ 3yrs. with anticipated PDUFA date as Mar 28- 2021
• The NDA & sNDA is based on P-III study assessing efficacy- safety- tolerability and PK of mirabegron in children and adolescents aged 3-<18yrs. with NDO and using clean intermittent catheterization
• In 2012- Myrbetriq tablets were initially approved in the US for adults with overactive bladder with symptoms of urge urinary incontinence- urgency and urinary frequency

 ­ Ref: PRNewswire | Image: Astellas