Fluvastatin Sodium

Lowers the risk of undergoing revascularization procedures. ANDA 90595, held by Mylan Pharms Inc. Fluvastatin Sodium.

As of Nov 15, 2026, ANDA 90595 (Fluvastatin Sodium), held by Mylan Pharms Inc, was first approved by FDA on Apr 11, 2012, with 3 approved supplements and 0 published complete response letters.

First approved: Apr 11, 2012
Supplements approved: 3
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other non-pharmacologic measures alone has been inadequate.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Apr 11, 2012	Original application	Approved	None posted

Products

2 strengths and forms


Fluvastatin SodiumEQ 20MG BASE · capsule;oral	Fluvastatin Sodium	Rx
Fluvastatin SodiumEQ 40MG BASE · capsule;oral	Fluvastatin Sodium	Rx

All 4 submissions, including labeling and manufacturing supplements


Sep 25, 2020	Supplement 7Labeling · Standard review	Approved	None posted
Sep 15, 2020	Supplement 3Labeling · Standard review	Approved	None posted
Mar 26, 2013	Supplement 2Labeling · Standard review	Approved	None posted
Apr 11, 2012	Original application	Approved	None posted

Identifiers

Application: ANDA 90595
Drugs@FDA: Overview at FDA
Company: Mylan Pharmaceuticals

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters