FDA approval: Clomiphene Citrate

AI Summary

The FDA has approved clomiphene citrate 50 mg tablets (ANDA220673) as an original generic application by Ascent Pharms Inc., effective 15 May 2026. This is a regulatory action confirming bioequivalence and manufacturing compliance; it does not report clinical efficacy, comparative trial data, or safety outcomes.

Plain-language summary

This is an FDA approval action for a generic clomiphene citrate formulation; it confirms regulatory authorization but does not report clinical trial outcomes or comparative efficacy.

Reported figures

Quoted from the source exactly as published.

Clinical bottom line

This approval permits marketing of a generic clomiphene citrate formulation in the United States. Clinicians should refer to the established labeling and clinical evidence for clomiphene citrate in its indicated uses (ovulation induction, male infertility); this record does not establish new clinical safety or efficacy data.

Caveats

• This record does not contain clinical trial results, efficacy data, or comparative safety information.
• The approval confirms regulatory and bioequivalence pathways only; clinical evidence supporting clomiphene citrate use is from prior studies of the active ingredient.
• No information provided on trial design, sample size, endpoints, or outcomes.
• No adverse event profile or post-market surveillance data included in this record.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

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