FDA APPROVES FORTICAL FOR POSTMENOPAUSAL OSTEOPOROSIS
Unigene Laboratories has received approval from the FDA for Fortical calcitonin-salmon
(rDNA origin) nasal spray, its patented nasal calcitonin product for the treatment
of postmenopausal osteoporosis.
Fortical will be manufactured at Unigene's production facility in Boonton, N.J. The final product will be packaged, marketed and sold in the U.S. by Upsher-Smith. Unigene will sell the filled product to Upsher-Smith and receive royalties on Upsher-Smith's sales.
Fortical is indicated for the treatment of postmenopausal osteoporosis in women greater than five years postmenopause with low bone mass relative to healthy premenopausal women.