Forteo

As of Nov 15, 2026, NDA 21318 (Forteo), held by Lilly, was first approved by FDA on Nov 26, 2002, with 25 approved supplements and 0 published complete response letters.

First approved: Nov 26, 2002
Review: Standard
Supplements approved: 25
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

FORTEO is indicated: For the treatment of postmenopausal women with osteoporosis at high risk for fracture (defined herein as having a history of osteoporotic fracture or multiple risk factors for fracture) or who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, FORTEO reduces the risk of vertebral and nonvertebral fractures. To increase bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture or who have failed or are intolerant to other available osteoporosis therapy.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 26 submissions below


Nov 16, 2020	Supplement 54Efficacy (new indication or use) · Standard review	Approved	Review Medication Guide Letter Label
Jul 22, 2009	Supplement 12Efficacy (new indication or use) · Standard review	Approved	Letter Label
Nov 26, 2002	Original applicationNew dosage form · Standard review	Approved	Review Label Letter

Products

2 strengths and forms


Forteo0.75MG/3ML (0.25MG/ML) · solution;subcutaneous	Teriparatide	Discontinued
Forteo0.56MG/2.24ML (0.25MG/ML) · solution;subcutaneous	Teriparatide	RxReference drug

All 26 submissions, including labeling and manufacturing supplements


Aug 3, 2026	Supplement 59Labeling · Standard review	Approved	Label Medication Guide Letter
Jul 24, 2024	Supplement 57Labeling · Standard review	Approved	Label
Sep 7, 2021	Supplement 56Labeling · Standard review	Approved	Review Label Letter
Nov 16, 2020	Supplement 54Efficacy (new indication or use) · Standard review	Approved	Review Medication Guide Letter Label
Apr 6, 2020	Supplement 53Labeling · Standard review	Approved	Review Label Letter
Oct 3, 2019	Supplement 52Labeling · Standard review	Approved	Label Letter
Apr 28, 2017	Supplement 51REMS	Approved	Letter
Nov 23, 2015	Supplement 44Manufacturing · Standard review	Approved	None posted
Sep 12, 2014	Supplement 41Manufacturing · Standard review	Approved	None posted
Aug 13, 2014	Supplement 40Manufacturing · Standard review	Approved	None posted
Apr 11, 2014	Supplement 39Manufacturing · Standard review	Approved	None posted
Mar 5, 2014	Supplement 37Manufacturing · Standard review	Approved	None posted
Jan 24, 2014	Supplement 38Manufacturing · Standard review	Approved	None posted
Aug 30, 2013	Supplement 36REMS	Approved	Label Letter
Aug 2, 2013	Supplement 35Manufacturing · Standard review	Approved	None posted
Mar 13, 2013	Supplement 33Manufacturing · Standard review	Approved	None posted
Feb 15, 2013	Supplement 32Manufacturing · Standard review	Approved	None posted
Mar 13, 2012	Supplement 27Labeling · Standard review	Approved	Letter
Aug 10, 2011	Supplement 26Labeling	Approved	Letter
Jul 22, 2009	Supplement 12Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jun 25, 2008	Supplement 16Manufacturing	Approved	Review Letter
Feb 28, 2008	Supplement 15Labeling · Standard review	Approved	Label Letter
May 19, 2007	Supplement 9Labeling · Standard review	Approved	Label Letter
Sep 3, 2004	Supplement 4Labeling · Standard review	Approved	Letter Label
Jun 2, 2004	Supplement 2Labeling · Standard review	Approved	Letter Label
Nov 26, 2002	Original applicationNew dosage form · Standard review	Approved	Review Label Letter

Identifiers

Application: NDA 21318
Drugs@FDA: Overview at FDA
Company: Lilly

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