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DATA GRAPHICS | Data Byte

FDA’s six new product approvals in March

First drug for Prader-Willi hyperphagia, first Xolair biosimilar

April 4, 2025 9:46 PM UTC

FDA’s six new product approvals in March included the first drug to treat hyperphagia in Prader-Willi syndrome: Vykat XR diazoxide choline.

Soleno Therapeutics Inc. (NASDAQ:SLNO) is launching the ATP-dependent potassium channel (KATP) agonist in April. It will be the company’s first product. WAC varies with dose, from $4,400 for 30 25mg tablets to $26,640 for 30 150mg tablets. After six weeks of titration, maintenance doses are 100-525mg per day, dependent on patient weight. At the top maintenance dose, a month’s supply would be $93,240...

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