Pravastatin Sodium · Regulatory label update

FDA supplemental approval: Pravastatin Sodium (Manufacturing (CMC))

U.S. Food and Drug Administration · August 6, 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 U.S. FDA supplemental approval (ANDA 077491) for manufacturing changes to pravastatin sodium tablets (10, 20, 30, and 80 mg oral formulations) by Senores Pharms, approved 6 August 2026. The record documents regulatory authorization of chemistry, manufacturing, and controls (CMC) modifications and does not contain clinical trial results, efficacy data, or comparative benefit information.

What was studied

Regulatory label update. United States (FDA).

Key findings

FDA approved supplemental application ANDA 077491 for pravastatin sodium on 2026-08-06 Supplement class: Manufacturing (CMC) Approved products: pravastatin sodium tablets 10 mg, 20 mg, 30 mg, and 80 mg oral formulations

Safety

This is a manufacturing/CMC supplement, not a clinical efficacy study; no trial data, safety outcomes, or comparative effectiveness information is reported. Sponsor: Senores Pharms

Who this may help

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

Plain-language summary

FDA supplemental approval for manufacturing changes to an established statin; documents regulatory authorization but does not report clinical efficacy or comparative outcome data.

Study design

As stated by the source record.

SettingUnited States (FDA)

Reported figures

Quoted from the source exactly as published.

Approval date2026-08-06

Application numberANDA077491

Caveats

This is a manufacturing/CMC supplement, not a clinical efficacy study; no trial data, safety outcomes, or comparative effectiveness information is reported.
Approval pertains to chemistry and manufacturing controls only; does not establish or re-evaluate clinical benefit.
No clinical population, sample size, or outcome metrics are described in this regulatory record.
No information on comparator formulations, bioequivalence, or clinical endpoints is provided.

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 clinical study design present.

Directness

insufficient

Manufacturing/CMC supplement; does not address clinical outcomes.

Consistency

insufficient

Single regulatory submission; no comparative data reported.

Risk of bias

insufficient

Regulatory record; clinical trial methodology not applicable.

Sample adequacy

insufficient

No clinical sample or population studied in this record.

Source abstract

Drugs@FDA record for application ANDA077491. This is a regulatory action record, not a clinical study. Brand name: PRAVASTATIN SODIUM. Active ingredient: PRAVASTATIN SODIUM. Sponsor: SENORES PHARMS. Submission type: SUPPL (supplement). Submission class: Manufacturing (CMC). Approval status date: 2026-08-06. Products: PRAVASTATIN SODIUM, TABLET, ORAL, PRAVASTATIN SODIUM 10MG; PRAVASTATIN SODIUM, TABLET, ORAL, PRAVASTATIN SODIUM 30MG; PRAVASTATIN SODIUM, TABLET, ORAL, PRAVASTATIN SODIUM 20MG; PRAVASTATIN SODIUM, TABLET, ORAL, PRAVASTATIN SODIUM 80MG.

Follow from this

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

Pravastatin SodiumSenores Pharms