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FDA Keeps Calcitonin Products On The Market But Narrows Osteoporosis Claim

Executive Summary

Saying its review found “no conclusive evidence of a causal relationship” between the products and cancer, agency is allowing continued marketing of Miacalcin and Fortical nasal sprays but limiting use to only those post-menopausal women for whom alternative treatments are not suitable.

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FDA Panel To Consider Calcitonin Drugs’ Need For Fracture Data In Light Of Potential Cancer Risk

The Reproductive Health Drugs and Drug Safety and Risk Management Advisory Committees will consider whether new calcitonin drugs for osteoporosis should show reduction in risk for fractures, a clinical benefit required of other osteoporosis medications.

Salmon-Derived Osteoporosis Drugs Face Upstream Struggle Against Cancer Concerns

A March 5 joint meeting of the FDA advisory committees for Reproductive Health Drugs and Drug Safety and Risk Management will consider whether the benefit of taking calcitonin salmon, a hormone that increases the amount of calcium in the bones, to treat postmenopausal osteoporosis outweighs the potential risk of cancer; in July 2012, the European Medicines Agency concluded the risk with long-term use was too great and eliminated the osteoporosis indication for calcitonins.

Tarsa Raises $28 Million Series B to Support Regulatory Filings of Oral Calcitonin

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