Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

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.

You may also be interested in...



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

Privately held firm believes oral calcitonin will enjoy several advantages over other osteoporosis therapies – ease of use compared to calcitonin nasal spray and safety compared to bisphosphonates.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS055994

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel