Quick answers
- What is Abaloparatide used for?
- The FDA-approved label (Tymlos, Radius Health, Inc., August 11, 2026) says: “TYMLOS is a human parathyroid hormone related peptide [PTHrP(1-34)] analog indicated for the: Treatment of postmenopausal women with osteoporosis at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapy. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Abaloparatide have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Abaloparatide?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Abaloparatide been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Abaloparatide?
- 1 company lists prescription products of Abaloparatide in the FDA NDC Directory, including Radius Health, Inc..
What Abaloparatide is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
TYMLOS is a human parathyroid hormone related peptide [PTHrP(1-34)] analog indicated for the: Treatment of postmenopausal women with osteoporosis at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapy. …
— FDA label: Tymlos, Radius Health, Inc., effective August 11, 2026. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution |
|---|---|
| Route | Subcutaneous |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Tymlos |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Radius Health, Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA208743 TYMLOS | Radius | April 28, 2017 | 10, latest August 3, 2026 2026: Labeling · 2025: Labeling · 2023: Labeling |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 1921075, 1921081 |
|---|---|
| SPL set ID of the quoted label | 712143d9-e21e-4013-bb3b-3426a21060a8 |
| FDA labels (SPL) | 1 |
| FDA applications | NDA208743 |
| Active ingredients (FDA) | ABALOPARATIDE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Tymlos, Radius Health, Inc., effective August 11, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →