Binosto

Treats osteoporosis in postmenopausal women. NDA 202344, held by Radius. Alendronate Sodium.

As of Nov 13, 2026, NDA 202344 (Binosto), held by Radius, was first approved by FDA on Mar 12, 2012, with 12 approved supplements and 0 published complete response letters.

First approved: Mar 12, 2012
Review: Standard
Supplements approved: 12
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

BINOSTO is a bisphosphonate indicated for: Treatment of osteoporosis in postmenopausal women Treatment to increase bone mass in men with osteoporosis Limitation of use: Optimal duration of use has not been determined. For patients at low-risk for fracture, consider drug discontinuation after 3 to 5 years of use 1.1 Treatment of Osteoporosis in Postmenopausal Women BINOSTO effervescent tablet 70 mg is indicated for the treatment of osteoporosis in postmenopausal women. For the treatment of osteoporosis, alendronate sodium increases bone mass and reduces the incidence of fractures, including those of the hip and spine (vertebral compression fractures). 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below

Date	Submission	Status	Documents
Mar 12, 2012	Original applicationNew dosage form · Standard review	Approved	Review Summary Review Label Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
BinostoEQ 70MG BASE · tablet, effervescent;oral	Alendronate Sodium	DiscontinuedReference drug

All 13 submissions, including labeling and manufacturing supplements


Feb 3, 2026	Supplement 22Labeling · Standard review	Approved	Letter Label Medication Guide
Oct 13, 2020	Supplement 15Labeling · Standard review	Approved	Letter Label
Jun 8, 2020	Supplement 13Labeling · Standard review	Approved	Label Letter
Dec 30, 2016	Supplement 11Labeling · Standard review	Approved	Letter Label
Mar 22, 2016	Supplement 10Labeling · Standard review	Approved	Letter
Jan 26, 2016	Supplement 9Manufacturing · Standard review	Approved	None posted
Apr 8, 2015	Supplement 8Labeling · Standard review	Approved	Letter Label
Feb 26, 2015	Supplement 7Labeling · Standard review	Approved	Label Letter
Dec 23, 2013	Supplement 6Manufacturing · Standard review	Approved	None posted
Aug 2, 2013	Supplement 2Manufacturing · Standard review	Approved	Label
Apr 19, 2013	Supplement 1Labeling · Standard review	Approved	Letter Label
Apr 17, 2013	Supplement 4Manufacturing · Standard review	Approved	None posted
Mar 12, 2012	Original applicationNew dosage form · Standard review	Approved	Review Summary Review Label Letter

Identifiers

Application: NDA 202344
Drugs@FDA: Overview at FDA
Company: Radius Health

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