ANI Pharmaceuticals Launches FDA-Approved Ketoconazole Shampoo For Healthy Hair

ANI Pharmaceuticals, Inc. has announced the official launch of its Ketoconazole Shampoo, 2%, following the final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA). This new product is a generic alternative to the well-known Nizoral®. According to IQVIA data from July 2024, the U.S. market for Ketoconazole Shampoo, 2% is valued at around $69.2 million annually.

Nikhil Lalwani, President and Chief Executive Officer of ANI, stated "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.”