MDRNA receives tentative FDA approval for generic osteoporosis drug

12/15/2008

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.

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