ANI Pharmaceuticals announces FDA approval, launch of L-Glutamine oral powder

ANI Pharmaceuticals 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.