Shots:

• The FDA has approved Myrbetriq (ER tablets) for NDO in children aged ≥3yrs. who weigh ≥35kg and Myrbetriq Granules (ER oral suspension) for NDO in pe children aged 3yrs. The FDA has granted pediatric exclusivity for Myrbetriq- resulting in an additional 6mos. period of market exclusivity
• The approval for the NDO indication is based on P-III study involves assessing Myrbetriq in children & adolescents aged 3-<18yrs with NDO using clean intermittent catheterization
• Myrbetriq tablets are available in the US while Myrbetriq granules are developed for use in younger children- or children with NDO who have difficulty in swallowing tablets and will be available in the US at the end of 2021

  Ref: PRNewswire | Image: Astellas