TheraRadar
Data updated: May 26, 2026

CALCITONIN-SALMON (calcitonin salmon)

Musculoskeletal Approved 2008-11-17

CALCITONIN-SALMON is indicated for the treatment of Symptomatic Paget’s disease of bone; Hypercalcemia; Post-menopausal osteoporosis.

Source: FDA Label • Apotex • Calcitonin

How CALCITONIN-SALMON Works

Calcitonin-salmon is a calcitonin receptor agonist that acts primarily on bone, with additional recognized effects on the kidneys and gastrointestinal tract. By binding to specific receptors on osteoclasts and osteoblasts, it mimics the actions of mammalian calcitonin but exhibits greater potency per milligram and a longer duration of action. These actions inhibit bone resorption and increase renal calcium excretion to lower serum calcium levels.

Source: FDA Label
10
Indications
--
Phase 3 Trials
17
Years on Market

Details

Status
Prescription
First Approved
2008-11-17
Routes
NASAL, INJECTION
Dosage Forms
SPRAY, METERED, INJECTABLE

CALCITONIN-SALMON Approval History

2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
17 FDA actions from 2008 to 2026
Mar 2026 ORIGINAL
Update
Sep 2025 ORIGINAL
Update
Jul 2025 ORIGINAL
Update

What CALCITONIN-SALMON Treats

3 indications

CALCITONIN-SALMON is approved for 3 conditions since its original approval in 2008. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Symptomatic Paget’s disease of bone
  • Hypercalcemia
  • Post-menopausal osteoporosis
Source: FDA Label

CALCITONIN-SALMON Competitive Set

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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

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Active Pipeline

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Key Completed Trials

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Trial Timeline

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

CALCITONIN-SALMON FDA Label Details

Indications & Usage

CALCITONIN-SALMON is indicated for the treatment of Symptomatic Paget’s disease of bone; Hypercalcemia; Post-menopausal osteoporosis.

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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.