FDA approves first Boniva generics to treat or prevent osteoporosis

The U.S. Food and Drug AdministrationThe U.S. Food and Drug Administration today approved the first generic versions of Boniva (ibandronate) tablets, a once-monthly product to treat or prevent osteoporosis in women after menopause.

The most common type of bone disease, osteoporosis, is characterized by low bone mass and structural deterioration of bone tissue, leading to bone fragility and an increased risk of fractures of the hip, spine, and wrist. Ibandronate is in a class of medications called bisphosphonates that help increase bone mass and reduce the chance of having a spinal fracture.

According to the National Institutes of Health, in the United States more than 40 million people either already have osteoporosis or are at high risk due to low bone mass.

"Men as well as women are affected by osteoporosis, a disease that can be prevented and treated," said Keith Webber, Ph.D., deputy director of the Office of Pharmaceutical Science in the FDA's Center for Drug Evaluation and Research. "For people who must manage their health conditions over time, it is important to have affordable treatment options."

Generic drugs approved by FDA have the same high quality and strength as brand-name drugs and provide a lower cost alternative. The generic manufacturing and packaging sites must pass the same quality standards as those of brand name drugs.

Apotex Inc., Orchid Healthcare, and Mylan Pharmaceuticals Inc. are the manufacturers that have gained FDA approval to make generic 150 milligram ibandronate tablets.

An FDA-required Medication Guide will be given to patients and caregivers when ibandronate is dispensed, describes the risks and adverse reactions people should be mindful of when using the drug. Ibandronate can cause serious side effects including: esophagus problems; low calcium levels in the blood; bone, joint, or muscle pain; severe jaw bone problems; and unusual thigh bone fractures.

In the clinical trials for Boniva, the most commonly observed adverse reactions were: back pain, indigestion (dyspepsia), pain in extremity, diarrhea, headache, and muscle pain (myalgia).

Information about the availability of generic ibandronate can be obtained from the manufacturers.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Most Popular Now

AstraZeneca takes next steps towards broad and equ…

AstraZeneca has taken the next steps in its commitment to broad and equitable global access to the University of Oxford’s COVID-19 vaccine, following landmark agreements ...

Johnson & Johnson announces acceleration of it…

Johnson & Johnson (NYSE: JNJ) (the Company) today announced that through its Janssen Pharmaceutical Companies (Janssen) it has accelerated the initiation of the Phase 1/2...

Low-cost dexamethasone reduces death by up to one …

In March 2020, the RECOVERY (Randomised Evaluation of COVid-19 thERapY) trial was established as a randomised clinical trial to test a range of potential treatments for C...

Sanofi invests to make France its world class cent…

Sanofi detailed plans on how the Company will make significant investments in France to increase its vaccines research and production capacities, and contribute in respon...

Calquence showed promising clinical improvement in…

Results published in Science Immunology showed that Calquence (acalabrutinib), a Bruton’s tyrosine kinase (BTK) inhibitor, reduced markers of inflammation and improved cl...

Super-potent human antibodies protect against COVI…

A team led by Scripps Research has discovered antibodies in the blood of recovered COVID-19 patients that provide powerful protection against SARS-CoV-2, the coronavirus ...

New consortium EUbOPEN will provide tools to unloc…

Almost twenty years after deciphering the human genome, our understanding of human disease is still far from complete. One of the most powerful and versatile tools to bet...

AstraZeneca to supply Europe with up to 400 millio…

AstraZeneca has reached an agreement with Europe's Inclusive Vaccines Alliance (IVA), spearheaded by Germany, France, Italy and the Netherlands, to supply up to 400 milli...

Up to 45 percent of SARS-CoV-2 infections may be a…

An extraordinary percentage of people infected by the virus behind the ongoing deadly COVID-19 pandemic never show symptoms of the disease, according to the results of a ...

Researchers identify potent antibody cocktail to t…

Researchers at the University of Maryland School of Medicine (UMSOM) evaluated several human antibodies to determine the most potent combination to be mixed in a cocktail...

Gilead announces results from Phase 3 Trial of rem…

Gilead Sciences, Inc. (Nasdaq: GILD) announced topline results from the Phase 3 SIMPLE trial in hospitalized patients with moderate COVID-19 pneumonia. This open-label st...

Mayo finds convalescent plasma safe for diverse pa…

Mayo Clinic researchers and collaborators have found investigational convalescent plasma to be safe following transfusion in a diverse group of 20,000 patients. The findi...