NDA 211939, held by Alvogen. Teriparatide.
As of Nov 14, 2026, NDA 211939 (Bonsity), held by Alvogen, was first approved by FDA on Oct 4, 2019, with 3 approved supplements and 0 published complete response letters.
Teriparatide injection 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, teriparatide injection 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.
| Nov 16, 2023 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Oct 4, 2019 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Bonsity0.56MG/2.24ML (0.25MG/ML) · solution;subcutaneous | Teriparatide | Rx |
| Aug 3, 2026 | Supplement 21Labeling · Standard review | Approved | |
| Jan 24, 2025 | Supplement 17Labeling · Standard review | Approved | |
| Nov 16, 2023 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Oct 4, 2019 | Original applicationNew formulation or manufacturer · Standard review | Approved |
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
