Amneal Pharmaceuticals, Inc. announced the launch of its authorized generic for Xyrem® (Sodium Oxybate) 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.
“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-Chief Executive Officers. “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.”
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The five recently approved products include:
|
|
Product |
Dosage Category
|
U.S. IQVIA sales (TTM April 2023) |
|
|
1 |
Medroxyprogesterone acetate injectable suspension, USP 150mg/mL (1mL) |
Injectable |
$114 million |
|
|
2 |
Dexmedetomidine hydrochloride in 0.9% sodium chloride injection, 4 mcg/mL (200 mcg/50 mL and 400 mcg/100 mL) |
Injectable |
$102 million |
|
|
3 |
Nelarabine injection, 250mg/50mL (5mg/mL) |
Injectable |
$29 million |
|
|
4 |
Dapsone 7.5% people |
Topical |
$47 million |
|
|
5 |
Mometasone furoate nasal spray, 50 mcg (OTC) |
Nasal Spray |
N/A – OTC |
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® by Amneal.
SOURCE: BusinessWire