USFDA Approves Zydus’ Ketoconazole Shampoo

Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Ketoconazole Shampoo, 2% in the United States. The product is a generic equivalent of Nizoral® Shampoo, 2%, which is used to treat dandruff and other fungal infections of the scalp.

As of 10:58 AM on March 10, 2025, Zydus Lifesciences Ltd was trading at ₹906.85, up ₹6.05 (0.67%) for the day, but down 18.54% over the past six months and 8.81% over the past year.

Product and Manufacturing 

Ketoconazole shampoo is an antifungal medication that helps manage conditions such as seborrheic dermatitis and dandruff. It works by reducing the growth of yeast and fungi on the scalp. Zydus will manufacture the product at its topical formulation facility in Changodar, Ahmedabad.

Regulatory Approval Process

The approval from the USFDA indicates that Zydus’ Ketoconazole Shampoo, 2% meets the regulatory standards for safety, efficacy, and quality. The ANDA pathway allows generic manufacturers to bring lower-cost alternatives to the market once patents or exclusivity periods for the reference drug expire.

Market Size and Competition

According to the reports, the annual sales of Ketoconazole Shampoo, 2% in the US market stood at $68.89 million. The product competes in the prescription and over-the-counter antifungal shampoo segment, where multiple generic and branded options are available.

Zydus’ Presence in the US Market

With this approval, Zydus now has a total of 418 final approvals from the USFDA. The company has filed 483 Abbreviated New Drug Applications (ANDAs) since it started the filing process in FY 2003-04. As of December 31, 2024, these filings have included a mix of oral, injectable, topical, and dermatological formulations.

Conclusion

All in all, Zydus Lifesciences continues to expand its product portfolio in the United States with this latest approval. The company remains active in the topical dermatology space, adding another formulation to its approved product list.

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