The US FDA Rejects Mallinckrodt’s Terlipressin Due to Doubts in its Risk-Benefit Profile

 The US FDA Rejects Mallinckrodt’s Terlipressin Due to Doubts in its Risk-Benefit Profile

The US FDA Rejects Mallinckrodt’s Terlipressin Due to Doubts in its Risk-Benefit Profile

Shots:

  • The US FDA has issued CRL to Terlipressin’s NDA for the treatment of hepatorenal syndrome type 1 (HRS-1) and requires more information to support a positive risk-benefit profile for the therapy in HRS-1 patients
  • The company is confident with its P-III CONFIRM study assessing the safety and efficacy of terlipressin in patients with HRS-1 for potential use in the US and Canada. On Jul 15, 2020, the FDA’s CRDAC voted to recommend approval of the therapy
  • Terlipressin is a potent vasopressin analog selective for V1 receptors being evaluated for HRS-1 in the US and Canada and is approved in multiple countries outside the US

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

Tuba Khan

Tuba Khan is an Editor and Digital Marketing expert at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in Lifesciences industry. She covers Pharma, Medical devices, Diagnostics and Digital health segment. Tuba also has an experience of digital and social media marketing and can run the campaign independently. She is also certified as a Digital marketer and social media marketer. She can be contacted on tuba@pharmashots.com

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