Jul 12 2023
Amneal Launches Authorized Generic of Xyrem – Drug Store News

“Generic Zyrem is a central nervous system depressant indicated for the treatment of cataplexy or excessive daytime sleepiness in patients seven years of age and older with narcolepsy.

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 seven years of age and older with narcolepsy.

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.’”

All information quoted from full article on Drugstorenews.com