Boniva

NDA 21455, held by Hoffmann La Roche. Ibandronate Sodium.

As of Nov 14, 2026, NDA 21455 (Boniva), held by Hoffmann La Roche, was first approved by FDA on May 16, 2003, with 15 approved supplements and 0 published complete response letters.

First approved: May 16, 2003
Review: Standard
Supplements approved: 15
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 16 submissions below


Nov 28, 2008	Supplement 7Efficacy (new indication or use)	Approved	Review Letter
Mar 24, 2005	Supplement 1Efficacy (new indication or use)	Approved	Letter Label Patient Package Insert
May 16, 2003	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label

Products

2 strengths and forms


BonivaEQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Ibandronate Sodium	DiscontinuedReference drug
BonivaEQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Ibandronate Sodium	DiscontinuedReference drug

All 16 submissions, including labeling and manufacturing supplements


Dec 7, 2016	Supplement 21Labeling · Standard review	Approved	Medication Guide Letter Label
Apr 8, 2015	Supplement 20Labeling · Standard review	Approved	Letter Label
Mar 18, 2015	Supplement 19Labeling · Standard review	Approved	Label Letter
Dec 17, 2014	Supplement 18Labeling · Standard review	Approved	Label Letter
Jun 18, 2014	Supplement 17Manufacturing · Standard review	Approved	None posted
Apr 19, 2013	Supplement 15Labeling · Standard review	Approved	Letter Label
Apr 19, 2013	Supplement 14Labeling · Standard review	Approved	Letter Label
Apr 5, 2013	Supplement 16Manufacturing · Standard review	Approved	None posted
Jul 1, 2011	Supplement 13REMS	Approved	Letter
Jan 25, 2011	Supplement 11REMS	Approved	Letter Label
Jan 8, 2010	Supplement 9Labeling · Standard review	Approved	Letter Label
Nov 28, 2008	Supplement 7Efficacy (new indication or use)	Approved	Review Letter
Feb 13, 2007	Supplement 5Labeling · Standard review	Approved	Letter Label
Jun 14, 2006	Supplement 3Labeling · Standard review	Approved	Letter
Mar 24, 2005	Supplement 1Efficacy (new indication or use)	Approved	Letter Label Patient Package Insert
May 16, 2003	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21455
Drugs@FDA: Overview at FDA
Company: Hoffmann-La Roche

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