Skip to main content

FDA Approves First Generic Boniva for Osteoporosis

March 19, 2012 — The US Food and Drug Administration (FDA) today approved the first generic versions of ibandronate (Boniva, Genentech), a once-a-month tablet to treat or prevent osteoporosis in postmenopausal women.
Three companies (Apotex, Orchid Healthcare, and Mylan Pharmaceuticals) received a green light to make generic 150-mg ibandronate tablets.
Ibandronate belongs to the bisphosphonate drug class, which help boost bone mass and reduce the risk for spinal fracture. The National Institutes of Health estimates that more than 40 million men and women have osteoporosis or are at high risk for it because of low bone mass.
"Men as well as women are affected by osteoporosis, a disease that can be prevented and treated," said Keith Webber, PhD, deputy director of the Office of Pharmaceutical Science in the FDA's Center for Drug Evaluation and Research, in an agency press release. "For people who must manage their health conditions over time, it is important to have affordable treatment options."
The FDA approval of generic ibandronate is conditioned on giving patients and caregivers a medication guide that describes the risks and adverse reactions associated with the drug. Potential adverse events include esophagus problems; decreased bloodstream levels of calcium; bone, joint, or muscle pain; severe jaw bone problems; and atypical femur fractures.
In October 2010, the agency required the labels for all bisphosphonates approved for osteoporosis to warn of the possible increased risk for 2 types of atypical femur fractures: subtrochanteric and diaphyseal.
Back pain, indigestion, pain in extremity, diarrhea, headache, and muscle pain were the most commonly observed adverse reactions in clinical trials for Boniva.

Comments

Post a Comment

Popular posts from this blog

Contact Precautions May Have Unintended Consequences

Contact precautions, including gloves, gowns, and isolated rooms, have helped stem the transmission of hospital pathogens but have also had some negative consequences, according to findings from a new study. Healthcare worker (HCWs) visited patients on contact precautions less frequently than other patients and spent less time with those patients when they did visit, report Daniel J. Morgan, MD, from the University of Maryland School of Medicine and the Veterans Affairs (VA) Maryland Health Care System, Baltimore, and colleagues. Moreover, patients on contact precautions also received fewer outside visitors. "Less contact with HCWs suggests that other unintended consequences of contact precautions still exist," Dr. Morgan and coauthors write. "The resulting decrease in HCW contact may lead to increased adverse events and a lower quality of patient care due to less consistent patient monitoring and poorer adherence to standard adverse event prevention methods (such...
Post a Comment
Read more

CareFusion Issues Update on Infant Breathing Product Recall

July 5, 2012 — Medical device maker CareFusion has issued an update reminding healthcare providers of its voluntary recall of its Air Life ™ Infant Breathing Circuit, initiated back in May. The US Food and Drug Administration (FDA) has classified this action as a class 1 recall, meaning there is a reasonable probability of serious adverse health consequences or death associated with use of the defective units. The update was posted July 2 on the FDA  Website. On May 29, 2012, CareFusion sent an  Urgent Recall Notice  to customers and distributors stating that the company had identified potential risks associated with the Air Life  Infant Breathing Circuit. The action was initiated after the company received complaints of the Y adapter within the breathing circuit developing cracks during patient use. "If a crack develops in the Y adapter, this could potentially result in a leak in the closed ventilation system, leading to a loss in the intended tidal volum...
Post a Comment
Read more

FDA Approves Tapentadol ER for Diabetic Neuropathy

August 29, 2012 — The US Food and Drug Administration (FDA) has approved tapentadol extended-release (ER) ( Nucynta , Janssen Pharmaceuticals, Inc) for the management of neuropathic pain associated with diabetic peripheral neuropathy (DPN) in adults for whom a continuous opioid analgesic is required over an extended time. It is the first opioid to receive this indication, the company notes in a statement today. DPN, the most common type of neuropathy, affects an estimated 16% of the more than 25 million Americans who have diabetes. The condition is often unreported and untreated, with an estimated 2 out of 5 cases not receiving care. Tapentadol ER is already approved for the treatment of moderate to severe chronic pain in adults requiring a continuous opioid analgesic for an extended period. It is a centrally acting synthetic analgesic, although the exact mechanism of action is unknown, the release states. "Although the clinical relevance is unclear," the company n...
4 comments
Read more