FDA Alerts
FDA Approves Botox to Treat Overactive Bladder
The US 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 new seasonal influenza vaccine made using novel technology
The US 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 Requiring Lower Recommended Dose for certain sleep drugs containing zolpidem
The US Food and Drug Administration today announced it is requiring the manufacturers of Ambien, Ambien CR, Edluar and Zolpimist, widely used sleep medications that contain the active ingredient zolpidem, to lower current recommended doses.
Andy Capp’s Hot Fries Recalled Due To Undeclared Soy Allergen
Today, ConAgra Foods, Omaha, Neb., in cooperation with the US Food and Drug Administration (FDA) is voluntarily recalling a limited number of packages of its Andy Capp’s Hot Fries flavor product that may contain the Andy Capp’s Cheddar Fries flavor, and, therefore, an undeclared allergen—soy. People who have an allergy or severe sensitivity to soy run the risk of serious or life-threatening allergic reaction if they consume these products. There have been no illnesses reported to date in connection with this product.
FDA Proposes New Food Safety Standards
The US 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 rules.
FDA Approves First Anti-Diarrheal Drug for HIV/AIDS Patients
The US 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.
Diarrhea is experienced by many HIV/AIDS patients and is a common reason why patients discontinue or switch their antiretroviral therapies. Fulyzaq is intended to be used in HIV/AIDS patients whose diarrhea is not caused by an infection from a virus, bacteria, or parasite.
Patients take Fulyzaq two times a day to manage watery diarrhea due to the secretion of electrolytes ...
FDA Approves Sirturo as Tuberculosis Option
On Dec. 28, the US 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 for Atrial Fibrillation Patients
The US 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 Varizig for Reducing Chickenpox Symptoms
The US Food and Drug Administration has approved Varizig for reducing the severity of chickenpox ( varicella zoster virus) infections in high risk individuals when given within four days after exposure.
FDA expands Tamiflu’s use to treat children younger than 1 year
The US 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.