The US FDA Approves New Indication and Formulation for Astellas’ Myrbetriq

 The US FDA Approves New Indication and Formulation for Astellas’ Myrbetriq

Astellas and Seagen Report EMA’s Acceptance of MAA for Enfortumab Vedotin to Treat Locally Advanced or Metastatic Urothelial Cancer

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

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

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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