ANI Pharmaceuticals, Inc. 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 Ketoconazole Shampoo, 2%. ANI’s Ketoconazole Shampoo, 2% is the generic version of the reference listed drug (RLD) Nizoral®.

"We are proud to announce the FDA approval and commercialization of Ketoconazole Shampoo, 2%, another limited competition product. ANI’s talented R&D team continues to execute on our key strategic priority to consistently and effectively launch new products that address the needs of patients,” stated Nikhil Lalwani, President and Chief Executive Officer of ANI.

U.S. annual sales for Ketoconazole Shampoo, 2% total approximately $69.2 million, based on July 2024 moving annual total (MAT) IQVIA data.

 

Source: anipharmaceuticals.com

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