FDA Approves Generic Boniva

From Associated Press (March 19, 2012)

WASHINGTON -- U.S. health regulators have approved the first low-cost versions of Roche’s blockbuster osteoporosis drug Boniva, which is used to prevent bone fractures.

The Food and Drug Administration said Monday it approved generic versions of the drug from three companies: Apotex Inc., Orchid Healthcare and Mylan Pharmaceuticals Inc. Generic drug makers launch cheaper versions of drugs after their patents have expired. Generic versions can cost anywhere from 30 to 80 percent less than the original branded drug.

More than 40 million people in the U.S. have osteoporosis or are at high risk for the disease, which leads to bone deterioration and fractions of the hip, spine and wrist. About one in five women over age 50 have osteoporosis, according to the National Institutes of Health. Osteoporosis is more common in women because of the drop in estrogen associated with menopause.

Boniva is part of a family of bone strengthening drugs known as bisphosphonates, which also includes Merck & Co. Inc.’s Fosamax and Novartis’ Reclast.

The main side effects reported with Boniva include back pain, indigestion, diarrhea and headaches.


 

Posted: March 2012


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