Astellas Reports the US FDA’s Acceptance of Priority Review for its NDO Therapy

January 7, 2021 Auto Bot Acceptance, Astellas, FDA, Priority Review, regulatory, reports, Tablets 0

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

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Financial Times

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