Amneal is debuting an authorized generic of Jazz Pharmaceuticals' Xyrem (Sodium Oxybate) oral solution CIII.
Sodium Oxybate oral solution, 0.5 g/ml is a central nervous system depressant indicated for the treatment of cataplexy or excessive daytime sleepiness in patients aged 7 years old and older with narcolepsy.
[Read more: Amneal touts 26 generic new product launches in 2022]
Additionally, Amneal has received ANDA approvals from the Food and Drug Administration for five complex generics products. Three recently approved products are injectables, including dexmedetomidine injection which is currently on the FDA's shortage product list.
“The launch of an authorized generic version of Xyrem represents another new complex product launch as we further expand our U.S. generics portfolio,” said Chirag and Chintu Patel, co-CEOs. “We are seeing continued momentum across our growing No. 4 U.S. Generics business and a steady cadence of innovation with new complex generics. By adding these new medicines to our portfolio, Amneal is on track to launch more than 30 new generics products this year.”
Read more: Amneal debuts 2 generics]