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ANI Pharmaceuticals Launches FDA-Approved Ketoconazole Shampoo For Healthy Hair

ANI Pharmaceuticals launches FDA-approved Ketoconazole Shampoo, 2%, a generic Nizoral® alternative.

Mrudula Kulkarni
By Mrudula Kulkarni
Managing Editor - Pharma Now
Sep 27, 2024Updated Jun 26, 2025 · 2 min read
ANI Pharmaceuticals Launches FDA-Approved Ketoconazole Shampoo For Healthy Hair
https://companieslogo.com/ani-pharmaceuticals/logo/
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Reviewed by Mrudula Kulkarni, Managing Editor - Pharma Now

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.”

 

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Mrudula Kulkarni
Written by
Mrudula Kulkarni
Managing Editor - Pharma Now

My international experience as a researcher in Taiwan for three years has equipped me with a global perspective, enabling me to create content that resonates with an international audience.



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