Rosuvastatin Calcium · Regulatory label update

FDA supplemental approval: Rosuvastatin Calcium (Labeling)

U.S. Food and Drug Administration · July 31, 2026

Regulatory Update Why this matters to you Expert discussion

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

AI Summary

This is a supplemental FDA approval for labeling changes to generic rosuvastatin calcium tablets (5, 10, 20, and 40 mg) submitted by Alkem Labs Ltd, approved on 31 July 2026. The record does not contain clinical trial results, efficacy data, or details of the labeling changes themselves.

What was studied

Regulatory label update.

Key findings

Safety

No safety or efficacy data are reported; this is an administrative approval action only.

Who this may help

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

Plain-language summary

FDA supplemental approval of labeling changes for generic rosuvastatin calcium; does not contain clinical trial data or efficacy evidence.

Reported figures

Quoted from the source exactly as published.

Approval date2026-07-31

Dosage strengths approved5 mg, 10 mg, 20 mg, 40 mg

Caveats

This record does not contain clinical trial results, efficacy data, or comparative evidence.
The specific labeling changes approved are not detailed in this regulatory record.
No safety or efficacy data are reported; this is an administrative approval action only.
Generalizability and clinical implications cannot be assessed from a labeling supplement 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.

Study design

insufficient

Regulatory action record; no study design applicable.

Directness

insufficient

Labeling supplement; does not report clinical outcomes or patient-relevant evidence.

Consistency

insufficient

Single regulatory action; consistency with prior approvals not stated.

Risk of bias

insufficient

Not applicable to regulatory labeling action.

Sample adequacy

insufficient

No clinical sample or trial population described.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Drugs@FDA record for application ANDA206465. This is a regulatory action record, not a clinical study. Brand name: ROSUVASTATIN CALCIUM. Active ingredient: ROSUVASTATIN CALCIUM. Sponsor: ALKEM LABS LTD. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-07-31. Products: ROSUVASTATIN CALCIUM, TABLET, ORAL, ROSUVASTATIN CALCIUM EQ 40MG BASE; ROSUVASTATIN CALCIUM, TABLET, ORAL, ROSUVASTATIN CALCIUM EQ 10MG BASE; ROSUVASTATIN CALCIUM, TABLET, ORAL, ROSUVASTATIN CALCIUM EQ 20MG BASE; ROSUVASTATIN CALCIUM, TABLET, ORAL, ROSUVASTATIN CALCIUM EQ 5MG BASE.

Follow from this

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

Rosuvastatin CalciumAlkem Labs