BLA 761398, held by Fresenius Kabi USA LLC. Denosumab-Bnht.
As of Nov 13, 2026, BLA 761398 (Bomyntra, Conexxence), held by Fresenius Kabi USA LLC, was first approved by FDA on Oct 29, 2025, with 1 approved supplement and 0 published complete response letters.
Conexxence is a RANK ligand (RANKL) inhibitor indicated for treatment: of postmenopausal women with osteoporosis at high risk for fracture to increase bone mass in men with osteoporosis at high risk for fracture of glucocorticoid-induced osteoporosis in men and women at high risk for fracture to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 29, 2025 | Original applicationEfficacy (new indication or use) · Standard review | Approved | |
| Mar 25, 2025 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Bomyntra120MG/1.7ML (70 MG/ML) · injection | Denosumab-Bnht | Rx |
| Conexxence60MG/ML · injection | Denosumab-Bnht | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 3, 2026 | Supplement 3Biosimilar | Approved | |
| Oct 29, 2025 | Original applicationEfficacy (new indication or use) · Standard review | Approved | |
| Mar 25, 2025 | Original application | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
