ANI's Generic L-Glutamine Oral Powder Hits Market, Targets $20.1M Annual Sales
ANI's Generic L-Glutamine Oral Powder Hits Market, Targets $20.1M Annual Sales
ANI Pharmaceuticals, Inc. (ANI or the Company) (NASDAQ:ANIP) today announced that following final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), the Company launched L-Glutamine Oral Powder. ANI's L-Glutamine Oral Powder is the generic version of the reference listed drug (RLD) Endari.
ANI製藥公司（ANI或公司）（納斯達克股票代碼：ANIP）今天宣佈，在美國食品藥品監督管理局（FDA）對其簡化新藥申請（ANDA）的最終批准後，該公司推出了L-谷氨醯胺口服粉。ANI的L-谷氨醯胺口服粉是參考上市藥物（RLD）Endari的仿製版本。
"The approval and launch of L-Glutamine Oral Powder, the first AA-rated approved generic to Endari, continues to demonstrate the strong capabilities and execution of our R&D team. We remain focused on ensuring that patients in need, and the providers who care for them, have access to our high-quality therapeutics," stated Nikhil Lalwani, President and Chief Executive Officer of ANI.
“L-谷氨醯胺口服粉是Endari首款獲得AA級批准的仿製藥，其批准和推出繼續表明我們研發團隊的強大能力和執行力。ANI總裁兼首席執行官Nikhil Lalwani表示，我們仍然專注於確保有需要的患者以及爲他們提供護理的提供者能夠獲得我們的高質量療法。
U.S. annual sales for L-Glutamine Oral Powder total approximately $20.1 million, based on May 2024 moving annual total (MAT) IQVIA data.
根據2024年5月的年度總銷售額（MAT）IQVIA數據，美國左旋谷氨醯胺口服粉的年銷售總額約爲2,010萬美元。