Amneal Pharmaceuticals, Inc. announced the launch of its authorized generic for Xyrem®1 oral solution CIII in the United States. Sodium Oxybate oral solution, 0.5 g/mL is a central nervous system depressant indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients seven years of age and older with narcolepsy. In addition, the Company announced it has received Abbreviated New Drug Application (ANDA) approvals from the U.S. Food and Drug Administration (“FDA”) for five complex generics products. Three recently approved products are injectables, including dexmedetomidine injection which is currently on the U.S. FDA shortage product list.
Medroxyprogesterone acetate Injectable suspension, USP 150mg/mL (1mL) is a generic version of Depo-Provera®. For full prescribing information,Dexmedetomidine hydrochloride in 0.9% sodium chloride injection, 4 mcg/mL (200 mcg/50 mL and 400 mcg/100 mL) is a generic version of Precedex® Injection.Nelarabine injection, 250mg/50mL (5mg/mL) is a generic version of Arranon® Injection.Dapsone 7.5% gel is a generic version of Aczone®.Mometasone furoate nasal spray, 50 mcg is a generic over-the-counter version of Nasonex®.IMPORTANT SAFETY INFORMATION FOR SODIUM OXYBATESodium Oxybate Oral Solution carries a boxed warning for central nervous system (CNS) depression and abuse and misuse. Taking Sodium Oxybate with other Central Nervous System (CNS) depressants has been associated with trouble breathing (respiratory depression), low blood pressure (hypotension), changes in alertness (drowsiness), fainting (syncope), and death.Sodium Oxybate is a form of gamma hydroxybutyrate (GHB). Abuse or misuse of illegal GHB alone or with other CNS depressants (drugs that cause changes in alertness or consciousness) may result in seizures, trouble breathing (respiratory depression), changes in alertness (drowsiness), coma, and death. Patients on Sodium Oxybate should be monitored for confusion, anxiety, and suicidality.Because of these risks, Sodium Oxybate is available only through the XYWAV and XYREM REMS. Patients must be enrolled in the XYWAV and XYREM REMS to receive Sodium Oxybate Oral Solution.
“The launch of an authorized generic version of Xyrem represents another new complex product launch as we further expand our U.S. generics portfolio,”
“We are seeing continued momentum across our growing #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.”
Chirag and Chintu Patel, Co-Chief Executive Officers.