Treats symptomatic Paget’s disease of bone. ANDA 212416, held by Custopharm Inc. Calcitonin Salmon.
As of Nov 15, 2026, ANDA 212416 (Calcitonin-Salmon), held by Custopharm Inc, was first approved by FDA on May 14, 2021, with 0 approved supplements and 0 published complete response letters.
Calcitonin salmon synthetic injection is a calcitonin, indicated for the following conditions: Treatment of symptomatic Paget’s disease of bone when alternative treatments are not suitable Treatment of hypercalcemia Treatment of postmenopausal osteoporosis when alternative treatments are not suitable. Fracture reduction efficacy has not been demonstrated Limitations of Use: Due to the possible association between malignancy and calcitonin salmon use, the need for continued therapy should be re-evaluated on a periodic basis ( 1.4, 5.3 ) 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 14, 2021 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Calcitonin-Salmon200 IU/ML · injectable;injection | Calcitonin Salmon | Rx |
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
