Is Calcitonin (salmon) FDA-approved?

Yes, as specific products: Miacalcin injection, generic calcitonin salmon injections and generic calcitonin salmon nasal sprays are FDA-approved, by prescription, for the uses in their labels.

Checked 1 Nov 2026. The sources are below.

Calcitonin (salmon)

Also: calcitonin salmon, salmon calcitonin, calcitonin-salmon, salcatonin, Miacalcin, Fortical, Calcimar

Status label in the Peptimes Library
FDA Approved
Routes in Peptimes
SubcutaneousIntramuscularNasal
Updated
1 Nov 2026

US regulatory status

FDA approval belongs to each product below, for its route and the uses in its label. Label uses are shortened unless quoted.

  • Miacalcin (calcitonin salmon) injection

    Subcutaneous or intramuscular

    Symptomatic Paget's disease of bone and postmenopausal osteoporosis when alternative treatments are not suitable, and hypercalcemia (high blood calcium). The label states that fracture reduction efficacy has not been demonstrated.

    Source: DailyMed label, checked 1 Nov 2026

  • Generic calcitonin salmon injection, from several manufacturers, with Miacalcin as the reference product

    Injection

    As stated on each product's label (approved through abbreviated new drug applications, ANDAs).

    Source: Drugs@FDA, checked 1 Nov 2026

  • Generic calcitonin salmon nasal spray (Apotex; PH Health)

    Nasal

    Postmenopausal osteoporosis in women more than 5 years past menopause when alternative treatments are not suitable. The label states that fracture reduction efficacy has not been demonstrated.

    Source: DailyMed label, checked 1 Nov 2026

  • Investigational

    No, for the products and uses above.

    Source: Drugs@FDA, checked 1 Nov 2026

What studies have looked at

Each point says who or what was studied and what the study reported, with its source and the date we checked it. These are findings from the sources cited, not advice or a promise of any result.

  • In humans

    In a 2-year placebo-controlled trial in women more than 5 years past menopause with low bone mass, without calcium supplements, lumbar spine bone density rose compared with placebo. No effect on the cortical bone of the forearm or hip was shown.

    Source: FDA label, calcitonin salmon nasal spray (ANDA 076396), checked 1 Nov 2026

  • Review of studies

    A review of 13 randomised trials found that calcitonin reduced acute pain from recent osteoporotic spinal fractures within a week. For chronic pain from older fractures, the reviewers found no convincing evidence of benefit.

    Source: PMID 21660557, checked 1 Nov 2026

  • Review of studies

    A review of 18 placebo-controlled trials found a higher share of people with cancer on salmon calcitonin in 15 of them. Most trials assessed new cancers poorly, and the authors said the evidence may suggest an association.

    Source: PMID 24259626, checked 1 Nov 2026

How to track it in Peptimes

Add calcitonin (salmon) in My Protocols and set the schedule you already follow: days of the week, times of day and a start date. Peptimes never suggests an amount when you log or schedule a dose. Its Library entry shows the status label “FDA Approved”; the entries above give the products it applies to.

  • Routes: subcutaneous, intramuscular or nasal. Choose the one that matches each dose.
  • Logging: the amount you took, the route and how you feel.
  • Injection sites: subcutaneous and intramuscular doses record the site, and Insights shows where you’ve injected and how recently. It never suggests where to inject next. Nasal doses skip this step.
  • Reminders and history: reminders at your times, Dose History, the Calendar and CSV or JSON export work as described on the peptide tracker app page.

Peptimes is a tracking app, not medical advice. Talk to a licensed clinician about your treatment. Peptimes doesn’t sell calcitonin or any other compound.

More sources

  • FDA, Drugs@FDA: NDA 017808 (Miacalcin injection), ANDA 076396 (Apotex nasal spray) and ANDA 076979 (PH Health nasal spray), checked 1 Nov 2026: product, route and marketing status. Miacalcin nasal spray and Fortical are listed as discontinued.
  • NLM, DailyMed, calcitonin salmon nasal solution (Par Health), checked 1 Nov 2026: the label for ANDA 076979.
  • FDA, Global Substance Registration System, Calcitonin salmon, checked 1 Nov 2026: its 32-amino-acid sequence and the names calcitonin (salmon) and calcitonin salmon, synthetic.

Brand names on this page are trademarks of their owners. Peptimes isn't affiliated with or endorsed by them.

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