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Drugs Approved by the FDA

Drug Name: Miacalcin (calcitonin-salmon) Nasal Spray

The following information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company: Sandoz Pharmaceuticals
Approval Status: Approved on August 17, 1995
Treatment for: post-menopausal osteoporosis

General Information

Miacalcin Nasal Spray (MNS) is a synthetic form of the hormone calcitonin, which inhibits bone loss. Previously available only in injectable form, Miacalcin is now available in a nasal spray.

Miacalcin is indicated for the treatment of postmenopausal osteoporosis in women who are more than five years past menopause and who have low bone mass compared with women before menopause. MNS is recommended for women who refuse or cannot tolerate estrogens or in whom estrogens should not be used. MNS should be taken with adequate calcium (at least 1000 mg elemental calcium per day) and vitamin D (400 international units) per day.

The medication has been used by thousands of women in 72 countries outside the U.S.

Clinical Results

Evidence of efficacy is based on increases in spinal bone mineral density observed in 551 postmenopausal women with osteoporosis who were studied for up to two years.

Side Effects

Nasal irritation and other symptoms of the nose such as dryness, redness, itching, or bleeding were the most commonly reported side effects.

Mechanism of Action

Miacalcin nasal spray, like natural calcitonin, acts primarily by inhibiting osteoclasts, the cells that break down existing bone, thereby decreasing the rate of bone breakdown, allowing the body to build bone naturally.


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Drug listing last updated on June 20, 2008

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