ANI Pharmaceuticals, Inc. (ANI) has announced the FDA approval and subsequent launch of Ketoconazole Shampoo, 2%, a generic equivalent to Nizoral® shampoo. This development marks a significant step for ANI as it expands its portfolio of generic prescription pharmaceutical products.
The approval, granted following the FDA's review of ANI's Abbreviated New Drug Application (ANDA), allows ANI to market Ketoconazole Shampoo, 2% as a cost-effective alternative to the branded Nizoral®.
Market Opportunity
According to July 2024 data from IQVIA, the U.S. market for Ketoconazole Shampoo, 2% amounts to approximately $69.2 million in annual sales. This represents a substantial commercial opportunity for ANI, potentially boosting the company's revenue and market position.
"We are proud to announce the FDA approval and commercialization of Ketoconazole Shampoo, 2%, another limited competition product," stated Nikhil Lalwani, President and Chief Executive Officer of ANI. He further emphasized that ANI's R&D team is dedicated to launching new products that address patient needs.
Strategic Alignment
The launch of Ketoconazole Shampoo, 2% aligns with ANI's broader strategy of strengthening its generics business and delivering innovation in established brands. By leveraging its research and development capabilities, ANI aims to provide high-quality, affordable treatment options for patients.
About Ketoconazole Shampoo
Ketoconazole shampoo is an antifungal medication used to treat fungal infections of the scalp, such as seborrheic dermatitis (dandruff) and tinea versicolor. The 2% strength is typically available by prescription and is used to reduce flaking, itching, and inflammation associated with these conditions.
ANI Pharmaceuticals Focus
ANI Pharmaceuticals, Inc. is a diversified biopharmaceutical company focused on developing, manufacturing, and marketing both branded and generic prescription pharmaceuticals. The company's portfolio includes products for diseases with high unmet medical needs, with a focus on scaling its Rare Disease business and leveraging its U.S.-based manufacturing footprint.
