HealthDay News — The FDA has approved the first generic versions of the once-monthly osteoporosis drug ibandronate (Boniva, Genentech).
The agency granted approvals to market 150 mg generic ibandronate tablets to Apotex Inc., Orchid Healthcare and Mylan Pharmaceuticals. Generic drugs are medically equivalent to the brand-name versions and are subject to the same quality standards, the FDA said in a press release.
Patients prescribed the drug will also receive a guide that explains potential serious reactions, including esophageal problems; pain in the muscles, bones or joints; low blood-calcium levels and uncommon femoral fractures. More common side effects include back pain, indigestion, extremity pain, diarrhea, headache and muscle pain.
Ibandronate is a bisphosphonate that helps increase bone mass, thus reducing the risk of fracture. Brand name Boniva, produced by Genentech, was approved by the FDA in 2003.