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Unigene Laboratories, Inc (UGNE) – a biopharmaceutical company that engages in the production, research, and delivery of peptides for medical use received approval from FDA today for Fortical Calcitonin-Salmon Nasal Spray, a product for treatment of postmenopausal osteoporosis. A new drug Fortical will be produced at the company’s production facility in Boonton, NJ. Fortical will be packaged, marketed and sold in the United States by Upsher-Smith. The CEO and President of Unigene Laboratories Dr. Warren Levy said “this is a pivotal accomplishment for the company and it will provide the rapidly growing population of postmenopausal osteoporosis sufferers with an additional option for managing the disease”. Fortical is directed for treatment in women with postmenopausal osteoporosis, who have higher than five years of post menopause with low bone mass relative to healthy premenopausal women. Other products of Unigene Laboratories include: oral insulin, injectable calcitonin for treatment of osteoporosis, oral dismopressin for primary nocturnal enuresis indications; oral leuprolide used for treatment of endometriosis and prostate cancer parathyroid hormone analog for the osteoporosis indications; glucose regularatory peptides for treatment of type 1 and type 2 diabetes. Unigene Labaratories were established in 1980 and are located in Fairfield, New Jersey. The company has licensed its oral PTH technology to GlxoSmithKline.
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