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制药公司（ANI或公司）（纳斯达克股票代码：ANIP）今天宣布，在美国食品药品监督管理局（FDA）对其简化新药申请（ANDA）的最终批准后，该公司推出了L-谷氨酰胺口服粉。ANI的L-谷氨酰胺口服粉是参考上市药物（RLD）Endari的仿制版本。
"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-谷氨酰胺口服粉是Endari首款获得AA级批准的仿制药，其批准和推出继续表明我们研发团队的强大能力和执行力。ANI总裁兼首席执行官Nikhil Lalwani表示，我们仍然专注于确保有需要的患者以及为他们提供护理的提供者能够获得我们的高质量疗法。
U.S. annual sales for L-Glutamine Oral Powder total approximately $20.1 million, based on May 2024 moving annual total (MAT) IQVIA data.
根据2024年5月的年度总销售额（MAT）IQVIA数据，美国左旋谷氨酰胺口服粉的年销售总额约为2,010万美元。