MDRNA receives tentative FDA approval for generic osteoporosis drug
BOTHELL, Wash. The Food and Drug Administration has given tentative approval to a generic version of Novartis Pharmaceuticals Corp.'s osteoporosis drug Miacalcin.
MDRNA announced Monday that it had received tentative approval for its generic calcitonin-salmon spray. It will receive full approval once Apotex's six-month exclusivity period ends in June 2009.
The branded version of the drug had sales of $147 million, according to MDRNA, based in the Seattle suburb of Bothell, Wash.