Miacalcin® (calcitonin salmon)

BL 20313 [BL 017808]

Miacalcin® (calcitonin salmon)

BL 20313 [BL 017808]

U.S. License Holder:

Mylan Ireland, Ltd.

Date of License:

August-17-1995 [July-03-1996]

Last Update:

Nov-15-2024

approved_indications FDA-Approved Indications

NDA 20313: MIACALCIN (calcitonin salmon) nasal spray is a calcitonin, indicated for the treatment of postmenopausal osteoporosis in women greater than 5 years postmenopause when alternative treatments are not suitable.

NDA 017808: MIACALCIN (calcitonin salmon) synthetic injection is a calcitonin, indicated for the following conditions:

Treatment of symptomatic Paget's disease of bone when alternative treatments are not suitable

Treatment of hypercalcemia

Treatment of postmenopausal osteoporosis when alternative treatments are not suitable. Fracture reduction efficacy has not been demonstrated.

approved_indications aBLA / 505(b)(2) Activity

aBLA / 505(b)(2) Approved by FDA

Fortical®: Upsher-Smith (August-2005)

Methodology

Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.

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