Treats postmenopausal osteoporosis. ANDA 76396, held by Apotex Inc. Calcitonin Salmon.
As of Nov 15, 2026, ANDA 76396 (Calcitonin-Salmon), held by Apotex Inc, was first approved by FDA on Nov 17, 2008, with 3 approved supplements and 0 published complete response letters.
Calcitonin Salmon (synthetic origin) Nasal Spray 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 spray has not been shown to increase bone mineral density in early postmenopausal women 1.1 Treatment of Postmenopausal Osteoporosis
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 17, 2008 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Calcitonin-Salmon200 IU/SPRAY · spray, metered;nasal | Calcitonin Salmon | Rx |
| Oct 31, 2015 | Supplement 6Labeling · Standard review | Approved | None posted |
| Oct 31, 2015 | Supplement 5Labeling · Standard review | Approved | None posted |
| Apr 25, 2012 | Supplement 3Labeling | Approved | None posted |
| Nov 17, 2008 | 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
