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Taiwan FDA withdraws marketing authorization for calcitonin nasal spray

Taiwan’s FDA has canceled marketing authorizations for calcitonin nasal sprays effective December 1 2013, and the products must be recalled within two months. According to the China Post, calcitonin nasal spray was first licensed in Taiwan in 1990.

The Taiwan FDA is the latest regulatory agency to act on concerns about cancer risks posed by calcitonin nasal spray, especially in light of uncertain benefits of its use for the prevention of osteoporosis in post-menopausal women.

Health Canada withdrew marketing authorization for the nasal sprays as of October 1, 2013; the EMA recommended against the use of the products in July 2012; and in March 2013, US FDA advisory panels concluded that the risks of calcitonin nasal spray for osteoporosis outweigh potential benefits.

Read China Post article.

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published on December 2, 2013

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