12:33 PM EST, 11/10/2025 (MT Newswires) -- A generic version of Pfizer's ( PFE ) Premarin hormone replacement therapy received US Food and Drug Administration approval for treating menopausal symptoms, the US Department of Health and Human Services said Monday.

The generic product is expected to improve affordability and access while ensuring the same safety and efficacy as the brand-name drug, according to the HHS.

The Department will also remove "misleading" FDA "black box" warnings from hormone replacement therapy products for menopause, according to a statement.

The agency is working with companies to modify product labeling to eliminate references to risks of cardiovascular disease and breast cancer, following a review of the scientific literature, the department stated.

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