The injectable drug is given once every six months to increase bone mass and strength.
One out of every two women over age 50 will break a bone in their lifetime due to osteoporosis, which causes bones to become brittle, according to an FDA statement.
Analysts think Prolia should bring Amgen billions in revenue after it is approved. Sales of the company's former top sellers, the anemia drugs Aranesp and Epogen, have dropped in recent years due to safety concerns and label restrictions.
