AbbVie Reports the US FDA’s Acceptance of BOTOX’s sBLA for Pediatric Patients with Neurogenic Detrusor Overactivity

 AbbVie Reports the US FDA’s Acceptance of BOTOX’s sBLA for Pediatric Patients with Neurogenic Detrusor Overactivity

AbbVie Reports the US FDA’s Acceptance of BOTOX’s sBLA for Pediatric Patients with Neurogenic Detrusor Overactivity

Shots:

  • The US FDA has accepted the Allergan’s sBLA to expand the BOTOX prescribing information for treating detrusor (bladder muscle) overactivity associated with an underlying neurologic condition in pediatric patients aged 5 -17yrs who have an inadequate response to or are intolerant of, or for any reason unwilling to continue anticholinergic medication
  • The sBLA is based on P-III study assessing BOTOX in 100+ pediatric patients with neurogenic detrusor overactivity and a long-term extension study. The company anticipates the PDUFA date to be in Q1’21 following a standard 10-mos. review
  • BOTOX is the first and only neurotoxin approved to treat leakage of urine (incontinence) due to overactive bladder caused by a neurologic condition in adults who still have leakage or cannot tolerate the side effects after trying an anticholinergic medication

Click here to read full press release/ article | Ref: AbbVie | Image: Pharmaceutical Technology

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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