Lysteda

Treats cyclic heavy menstrual bleeding in females of reproductive potential. NDA 22430, held by J Molner. Tranexamic Acid.

As of Nov 15, 2026, NDA 22430 (Lysteda), held by J Molner, was first approved by FDA on Nov 13, 2009, with 6 approved supplements and 0 published complete response letters.

First approved: Nov 13, 2009
Review: Priority
Supplements approved: 6
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Tranexamic acid USP tablets are indicated for the treatment of cyclic heavy menstrual bleeding in females of reproductive potential.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Nov 13, 2009	Original applicationNew dosage form · Priority review	Approved	Summary Review Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Lysteda650MG · tablet;oral	Tranexamic Acid	RxReference drug

All 7 submissions, including labeling and manufacturing supplements


Dec 7, 2020	Supplement 9Labeling · Standard review	Approved	Label Letter
May 23, 2016	Supplement 6Manufacturing · Priority review	Approved	None posted
Oct 23, 2015	Supplement 5Manufacturing · Priority review	Approved	None posted
Oct 3, 2013	Supplement 4Labeling · Standard review	Approved	Label Letter
Aug 21, 2013	Supplement 3Labeling · Standard review	Approved	Letter Label
Apr 6, 2011	Supplement 2Labeling · Standard review	Approved	Review Letter Label
Nov 13, 2009	Original applicationNew dosage form · Priority review	Approved	Summary Review Review Letter Label

Identifiers

Application: NDA 22430
Drugs@FDA: Overview at FDA
Company: J. Molner

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