US Food and Drug Administration (US FDA) has approved Unigene Laboratories’s modification for a key enzyme for it’s patented manufacturing process for calcitonin, the active ingredient in Fortical, a nasal spray product for the treatment of osteoporosis.

US Food and Drug Administration (FDA) has approved the improvements for Unigene Laboratories’s patented manufacturing process for calcitonin, the active ingredient in Fortical, nasal spray product for the treatment of osteoporosis.

US FDA is still reviewing a second improvement to the production process that, if approved, is expected to improve batch yields of the product by a factor of three.

The leading osteoporosis products fall within a class of drugs called bisphosphonates. They are effective in reducing the incidence of fracture and in preventing bone loss and  associated with osteonecrosis, an infrequent but severe condition.

US FDA is conducting a safety review of this class of drugs regarding a possible increased risk of atrial fibrillation, an established risk factor for stroke.