Effient

Reduces thrombotic cardiovascular events (including stent thrombosis). NDA 22307, held by Cosette. Prasugrel Hydrochloride.

As of Nov 13, 2026, NDA 22307 (Effient), held by Cosette, was first approved by FDA on Jul 10, 2009, with 13 approved supplements and 0 published complete response letters.

First approved: Jul 10, 2009
Review: Priority
Supplements approved: 13
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Effient is a P2Y 12 platelet inhibitor indicated for the reduction of thrombotic cardiovascular events (including stent thrombosis) in patients with acute coronary syndrome who are to be managed with percutaneous coronary intervention (PCI) as follows: Patients with unstable angina or non-ST-elevation myocardial infarction (NSTEMI). Patients with ST-elevation myocardial infarction (STEMI) when managed with either primary or delayed PCI. 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below


Jul 12, 2016	Supplement 14Efficacy (new indication or use) · Priority review	Approved	Letter Label
Oct 16, 2013	Supplement 8Efficacy (new indication or use) · Standard review	Approved	Other Review Label Letter
Jul 10, 2009	Original applicationNew molecular entity · Priority review	Approved	Label Letter Review Summary Review

Products

2 strengths and forms


EffientEQ 5MG BASE · tablet;oral	Prasugrel Hydrochloride	RxReference drug
EffientEQ 10MG BASE · tablet;oral	Prasugrel Hydrochloride	RxReference drug

All 14 submissions, including labeling and manufacturing supplements


Dec 22, 2020	Supplement 18Labeling · Standard review	Approved	Label Medication Guide Letter
Mar 28, 2019	Supplement 16Labeling · Standard review	Approved	Label Letter
Mar 9, 2018	Supplement 15Labeling · Standard review	Approved	Letter Label
Jul 12, 2016	Supplement 14Efficacy (new indication or use) · Priority review	Approved	Letter Label
Jan 14, 2016	Supplement 13Labeling · Standard review	Approved	Label Letter
Jul 7, 2015	Supplement 12Labeling · Standard review	Approved	Letter Label
Nov 19, 2013	Supplement 10Labeling · Standard review	Approved	Label Letter
Oct 16, 2013	Supplement 8Efficacy (new indication or use) · Standard review	Approved	Other Review Label Letter
Nov 30, 2012	Supplement 7Labeling	Approved	Label Letter
Mar 23, 2012	Supplement 6REMS	Approved	Letter
Sep 27, 2011	Supplement 3Labeling	Approved	Label Letter
Dec 6, 2010	Supplement 2Labeling	Approved	Letter Label
Apr 16, 2010	Supplement 1Manufacturing · Priority review	Approved	Label Letter
Jul 10, 2009	Original applicationNew molecular entity · Priority review	Approved	Label Letter Review Summary Review

Identifiers

Application: NDA 22307
Drugs@FDA: Overview at FDA
Company: Cosette

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