Emoal因针对Jazz Pharma的Xyrem的仿制药而赢得FDA批准

Amneal Pharmaceuticals (NASDAQ:AMRX) announced on Thursday that the U.S. Food and Drug Administration (FDA) approved its generic product targeting Jazz Pharmaceuticals’ (NASDAQ:JAZZ) sleep disorder therapy Xyrem.

The approval of Amneal’s (NASDAQ:AMRX) Abbreviated New Drug Application (ANDA) allows the market entry of its sodium oxybate oral solution 500 mg/mL.

Xyrem, indicated in the U.S. for cataplexy or excessive daytime sleepiness in patients aged seven years and older with narcolepsy, helped Jazz (NASDAQ:JAZZ) generate $233.8M in net revenue last year, representing ~6% of its total net product sales.

“By offering sodium oxybate, Amneal is providing patients, providers, and payers with a more affordable alternative in a therapeutic category that has historically been limited to a single manufacturer,” said Tony Rosa, Amneal’s (NASDAQ:AMRX) head of sales and marketing for retail generics.