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.
“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.
U.S. annual sales for L-Glutamine Oral Powder total approximately $20.1 million, based on May 2024 moving annual total (MAT) IQVIA data.
