Amneal Launches Authorized Generic for Xyrem (sodium oxybate) and Receives FDA Approval for Five Complex Generics in the Second Quarter - Seite 2

Nasal Spray

N/A – OTC

Medroxyprogesterone acetate Injectable suspension, USP 150mg/mL (1mL) is a generic version of Depo-Provera. For full prescribing information, see package insert located here.

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. For full prescribing information, see package insert located here.

Nelarabine injection, 250mg/50mL (5mg/mL) is a generic version of Arranon Injection. For full prescribing information, see package insert located here.

Dapsone 7.5% gel is a generic version of Aczone. For full prescribing information, see package insert located here.

Mometasone furoate nasal spray, 50 mcg is a generic over-the-counter version of Nasonex. For full prescribing information, see package insert located here.

IMPORTANT SAFETY INFORMATION FOR SODIUM OXYBATE

Sodium 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.

For full prescribing information, see package insert located here.

References:

1. Xyrem is a registered trademark of Jazz Pharmaceuticals, Inc.

About Amneal

Amneal Pharmaceuticals, Inc. (NYSE: AMRX), headquartered in Bridgewater, NJ, is a fully integrated global pharmaceuticals company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of approximately 270 pharmaceutical products, primarily within the United States. In its Generics segment, the Company is expanding across a broad range of complex product categories and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceuticals focused primarily on central nervous system and endocrine disorders, with a pipeline focused on unmet needs. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. For more information, please visit www.amneal.com.