Treats postmenopausal osteoporosis. ANDA 76979, held by Ph Health. Calcitonin Salmon.
As of Nov 15, 2026, ANDA 76979 (Calcitonin-Salmon), held by Ph Health, was first approved by FDA on Jun 8, 2009, with 4 approved supplements and 0 published complete response letters.
Calcitonin Salmon Nasal Solution is a calcitonin, indicated for the treatment of postmenopausal osteoporosis in women greater than 5 years postmenopause 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. ( 1.2, 5.4 ) Calcitonin Salmon Nasal Solution has not been shown to increase bone mineral density in early postmenopausal women 1.1 Treatment of Postmenopausal Osteoporosis
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 8, 2009 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Calcitonin-Salmon200 IU/SPRAY · spray, metered;nasal | Calcitonin Salmon | Rx |
| Aug 26, 2020 | Supplement 14Labeling · Standard review | Approved | None posted |
| Oct 31, 2015 | Supplement 13Labeling · Standard review | Approved | None posted |
| Jul 12, 2012 | Supplement 10Labeling · Standard review | Approved | None posted |
| Apr 18, 2012 | Supplement 8Labeling | Approved | None posted |
| Jun 8, 2009 | Original application | 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
