Atorvastatin 40mg: clinical trials recruiting now
FDA drug label
- FDA-approved
- Yes. Atorvastatin 40mg appears in the FDA drug-label database. Marketed as Atorvastatin Calcium.
- Drug class
- HMG-CoA Reductase Inhibitor (FDA established pharmacologic class)
- Mechanism of action
- Hydroxymethylglutaryl-CoA Reductase Inhibitors (as stated on the FDA label)
FDA-approved use
Atorvastatin calcium tablets is indicated: To reduce the risk of: Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: Adults with primary hyperlipidemia. Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia Hypertriglyceridemia
FDA recalls / enforcement
| Reason (FDA) | Classification | Status | Initiated |
|---|---|---|---|
| Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates. — Ranbaxy Inc. | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2012-11-09 |
| CGMP Deviations: recalling drug products following an FDA inspection. — Accord Healthcare, Inc. | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2023-02-07 |
| Failed Dissolution Specifications — Ascend Laboratories, LLC | Class II (FDA: may cause temporary or reversible harm) | Ongoing | 2025-09-19 |
| Subpotent drug — Dr. Reddy's Laboratories, Inc. | Class III (FDA: unlikely to cause harm) | Terminated | 2015-05-06 |
| Failed Impurities/Degradation Specifications: Out of Specification results for related substance. — Dr. Reddy's Laboratories, Inc. | Class III (FDA: unlikely to cause harm) | Terminated | 2022-03-16 |
Phase breakdown
Conditions being studied
| Condition | Trials |
|---|---|
| Migraine | 2 |
| COPD | 1 |
| Chronic Migraine | 1 |
| Episodic Migraine | 1 |
| HIV | 1 |
| Tuberculosis, Pulmonary | 1 |
Recruiting trials involving Atorvastatin 40mg
- Atorvastatin to Reduce Inflammation After Tuberculosis Treatment Completion
- Prophylactic Treatment With Atorvastatin for Chronic Migraine (ChronicStatinMig)
- Prophylactic Treatment With Atorvastatin for Episodic Migraine.
Common questions
Is Atorvastatin 40mg FDA-approved?
Yes, marketed as Atorvastatin Calcium.
How many recruiting trials involve Atorvastatin 40mg?
3 recruiting trials across 6 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.