Hydrocortisone · Regulatory approval

FDA approval: Hydrocortisone

U.S. Food and Drug Administration · July 16, 2026

Regulatory Update Why this matters to you Expert discussion

An action by a regulator. Authoritative on labelling and availability.

AI Summary

The FDA approved an abbreviated new drug application (ANDA) for a generic hydrocortisone 2.5% topical lotion formulation manufactured by Rising Pharmaceuticals on 16 July 2026. This is a regulatory action confirming bioequivalence and manufacturing quality; it does not report clinical efficacy or comparative trial outcomes.

What was studied

Regulatory approval. Intervention: Hydrocortisone 2.5% lotion, topical formulation.

Key findings

Approval granted for hydrocortisone 2.5% lotion, topical formulation on 2026-07-16

Safety

This record does not contain clinical trial results, efficacy data, or safety outcome measures.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

FDA approval of a generic hydrocortisone topical lotion formulation; this is a regulatory action, not a clinical efficacy study.

Study design

As stated by the source record.

InterventionHydrocortisone 2.5% lotion, topical formulation

Reported figures

Quoted from the source exactly as published.

Active ingredient concentration2.5%

Approval date2026-07-16

Caveats

This record does not contain clinical trial results, efficacy data, or safety outcome measures.
The approval is based on bioequivalence demonstration (typical for ANDA submissions) and manufacturing quality; these details are not provided in this record.
No comparator arm, control group, or comparative efficacy data reported.
This is a generic product approval; clinical activity is presumed from reference product but not re-demonstrated here.

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.

Study design

insufficient

Regulatory approval record; no clinical study design applicable.

Directness

insufficient

Record does not contain clinical trial data or outcomes.

Consistency

insufficient

No comparative efficacy data reported in this approval record.

Risk of bias

insufficient

Regulatory submission; clinical trial quality not described.

Sample adequacy

insufficient

No clinical sample reported in this approval record.

Source abstract

Drugs@FDA record for application ANDA218298. This is a regulatory action record, not a clinical study. Brand name: HYDROCORTISONE. Active ingredient: HYDROCORTISONE. Sponsor: RISING. Submission type: ORIG (original application). Approval status date: 2026-07-16. Products: HYDROCORTISONE, LOTION, TOPICAL, HYDROCORTISONE 2.5%.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

RisingHydrocortisone