FDA LABEL RECORD
Calcitonin Salmon
CALCITONIN SALMON. FDA prescribing information for this product, as published on the retrieval date below.
AS THE LABEL RECORDS IT
Product details
| Brand name | Calcitonin Salmon |
|---|---|
| Generic name | CALCITONIN SALMON |
| Labeller | Apotex Corp. |
| Route | NASAL |
| Label version | 13 |
| Effective | 2026-09-10 |
| Retrieved by this site | 2026-10-03 |
| Full label | https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c82eb602-12e1-692b-d660-f8d5b5736b54 |
INDICATIONS AND USAGE
Quoted from the FDA label
1 INDICATIONS AND USAGE 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 ( 1.1 ) 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 ( 1.2 ) 1.1 Treatment of Postmenopausal Osteoporosis Calcitonin Salmon (synthetic origin) Nasal Spray is indicated for the treatment of postmenopausal osteoporosis in women greater than 5 years postmenopause. Fracture reduction efficacy has not been demonstrated. Calcitonin Salmon (synthetic origin) Nasal Spray should be reserved for patients for whom alternative treatments are not suitable (e.g., patients for whom other therapies are contraindicated or for patients who are intolerant or unwilling to use other therapies). 1.2 Important 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 [see Warnings and Precautions (5.4)] . Calcitonin Salmon (synthetic origin) Nasal Spray has not been shown to increase spinal bone mineral density in early postmenopausal women.
What this page is
A reproduction of a public FDA label record. Everything quoted above is the labeller's wording as published by the FDA, not this site's. Nothing here is regulatory, legal or medical advice, and a label being reproduced says nothing about whether a product is available in any particular country. Labels are revised often; the retrieval date above says when this copy was taken, and the full current label is at the link.
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