FDA approves over-the-counter Oxytrol for Women to treat overactive bladder
The U.S. Food and Drug Administration today approved Oxytrol for Women, the first over-the-counter treatment for overactive bladder in women ages 18 years and older.
Archive for the ‘Drug Safety Information Podcasts’ category
FDA approves Exjade to remove excess iron in patients with genetic blood disorder
The U.S. Food and Drug Administration today expanded the approved use of Exjade (deferasirox) to treat patients ages 10 years and older who have chronic iron overload resulting from a genetic blood disorder called non-transfusion-dependent thalassemia (NTDT).
FDA approves Botox to treat overactive bladder
The U.S. Food and Drug Administration today expanded the approved use of Botox (onabotulinumtoxinA) to treat adults with overactive bladder who cannot use or do not adequately respond to a class of medications known as anticholinergics.
FDA approves Octaplas to treat patients with blood clotting disorders
The U.S. Food and Drug Administration today approved Octaplas, a pooled plasma (human) blood product for the replacement of clotting proteins (coagulation factors) in certain medical conditions where patients have insufficient levels. Clotting protein deficiencies can cause excessive bleeding or excessive clotting.
FDA approves new seasonal influenza vaccine made using novel technology
The U.S. Food and Drug Administration today announced that it has approved Flublok, the first trivalent influenza vaccine made using an insect virus (baculovirus) expression system and recombinant DNA technology. Flublok is approved for the prevention of seasonal influenza in people 18 through 49 years of age.
FDA permits marketing of first test that can simultaneously identify 11 causes of infectious gastroenteritis
The U.S. Food and Drug Administration today allowed marketing for the first test that can simultaneously detect 11 common viral, bacterial and parasitic causes of infectious gastroenteritis from a single patient sample.
FDA requiring lower recommended dose for certain sleep drugs containing zolpidem
The U.S. Food and Drug Administration today announced it is requiring the manufacturers of Ambien, Ambien CR, Edluar and Zolpimist, widely used sleep drugs that contain the active ingredient zolpidem, to lower current recommended doses. Ambien and Ambien CR are also available as generics. New data show that zolpidem blood levels in some patients may […]
FDA issues draft guidance on abuse-deterrent opioids
The U.S. Food and Drug Administration today issued a draft guidance document to assist industry in developing new formulations of opioid drugs with abuse-deterrent properties.
FDA proposes new food safety standards for foodborne illness prevention and produce safety
The U.S. Food and Drug Administration today proposed two new food safety rules that will help prevent foodborne illness. The proposed rules implement the landmark, bipartisan FDA Food Safety Modernization Act (FSMA) and are available for public comment for the next 120 days. The FDA encourages Americans to review and comment on these important proposed […]
FDA approves first anti-diarrheal drug for HIV/AIDS patients
The U.S. Food and Drug Administration today approved Fulyzaq (crofelemer) to relieve symptoms of diarrhea in HIV/AIDS patients taking antiretroviral therapy, a combination of medicines used to treat HIV infection.
FDA approves first drug to treat multi-drug resistant tuberculosis
On Dec. 28, the U.S. Food and Drug Administration approved Sirturo (bedaquiline) as part of combination therapy to treat adults with multi-drug resistant pulmonary tuberculosis (TB) when other alternatives are not available.
FDA approves Eliquis to reduce the risk of stroke, blood clots in patients with non-valvular atrial fibrillation
The U.S. Food and Drug Administration today approved the anti-clotting drug Eliquis (apixaban), an oral tablet used to reduce the risk of stroke and dangerous blood clots (systemic embolism) in patients with atrial fibrillation that is not caused by a heart valve problem.
FDA approves new orphan drug for rare cholesterol disorder
On Dec. 21, the U.S. Food and Drug Administration approved Juxtapid (lomitapide) to reduce low-density lipoprotein (LDL) cholesterol, total cholesterol, apolipoprotein B, and non-high-density lipoprotein (non-HDL) cholesterol in patients with homozygous familial hypercholesterolemia (HoFH). Juxtapid is intended for use in combination with a low fat diet and other lipid-lowering treatments.
Federal judge enters order imposing restrictions on Sunland Inc.
U.S. District Judge William P. Johnson of the District of New Mexico has signed a consent decree imposing requirements on Sunland Inc., a manufacturer and distributor of peanut products linked to an outbreak of Salmonella Bredeney, to keep potentially harmful products from entering the marketplace, the U.S. Food and Drug Administration said today.
FDA approves Varizig for reducing chickenpox symptoms
The U.S. Food and Drug Administration approved Varizig, for reducing the severity of chicken pox (varicella zoster virus) infections in high risk individuals when given within four days after exposure.
FDA approves Gattex to treat short bowel syndrome
The U.S. Food and Drug Administration today approved Gattex (teduglutide) to treat adults with short bowel syndrome (SBS) who need additional nutrition from intravenous feeding (parenteral nutrition).
FDA expands Tamiflu’s use to treat children younger than 1 year
The U.S. Food and Drug Administration today expanded the approved use of Tamiflu (oseltamivir) to treat children as young as 2 weeks old who have shown symptoms of flu for no longer than two days.
Invacare signs consent decree to correct wheelchair manufacturing problems
The Food and Drug Administration announced today that medical device maker and distributor, Invacare Corp., and two of its top executives have signed a consent decree of permanent injunction requiring the company to stop manufacturing, designing, and distributing manual and powered wheelchairs and wheelchair components.
FDA permits marketing of device to seal lung punctures
The U.S. Food and Drug Administration today allowed marketing of the Bio-Seal Lung Biopsy Tract Plug System, a device that seals punctures left by biopsies performed to confirm a diagnosis of suspected lung conditions.