Generic Versions of Boniva Approved

Boniva approved as a generic formulation by FDA

/ Author:  / Reviewed by: Joseph V. Madia, MD

(RxWiki News) Post-menopausal women with osteoporosis now have three generic alternatives to the prescription drug Boniva, a once-monthly tablet designed to treat or prevent bone loss.

Boniva has the generic name ibandronate, and it falls under a class of drugs called bisphosphonates. Three different pharmaceutical companies have been given the go-ahead to manufacture generic Boniva, which means that older women at risk of bone fractures now have lower cost options for their prescriptions.

"Ask your doctor about switching to generic Boniva."

Osteoporosis is common in older people, especially women after menopause. Ten million Americans over the age of 50 are estimated to have the condition.

It's characterized by a loss of bone mass and density, making bones prone to fracture.

For a person with osteoporosis, a bump or a fall that would not affect a healthy skeleton can cause painful breaks. Once you've had one break, it's more likely you will experience another.

Bisphosphonates are the most commonly prescribed medicine to treat osteoporosis. They're taken orally, and works to prevent the breakdown of bone tissue and boost bone strength at the same time.

According to the FDA announcement, Apotex Inc., Orchid Healthcare, and Mylan Pharmaceuticals Inc. are the companies approved to manufacture the generic versions of Boniva in 150 milligram tablets.

Boniva is currently manufactured by the pharmaceutical company Roche.

The FDA requires a Medication Guide to be given to patients and caregivers describing the risks and side effects of the drug. Side effects include esophagus problems; low calcium levels in the blood; bone, joint, or muscle pain; severe jaw bone problems; and unusual thigh bone fractures, according to the FDA.

Reviewed by: 
Review Date: 
March 20, 2012
Last Updated:
March 20, 2012