FDA Alerts
FDA Reminder About Prescribing Too Much Acetaminophen
FDA is reminding health care professionals to stop prescribing and pharmacists to stop dispensing prescription combination drug products that contain more than 325 milligrams (mg) of acetaminophen per tablet, capsule, or other dosage unit.
FDA Approves Sylvant for Rare Castleman’s Disease
The U.S. Food and Drug Administration today approved Sylvant (siltuximab) to treat patients with multicentric Castleman’s disease (MCD), a rare disorder similar to lymphoma (cancer of the lymph nodes).
FDA Approves New Rx for Stomach Cancer
The U.S. Food and Drug Administration today approved Cyramza (ramucirumab) to treat patients with advanced stomach cancer or gastroesophageal junction adenocarcinoma, a form of cancer located in the region where the esophagus joins the stomach.
New Treatment Approved for Ragweed Allergy
The FDA today approved Ragwitek, the first allergen extract administered under the tongue (sublingually) to treat short ragweed pollen induced allergic rhinitis (hay fever), with or without conjunctivitis (eye inflammation), in adults 18 years through 65 years of age.
FDA Approves New Diabetes Rx
The U.S. Food and Drug Administration today approved Tanzeum (albiglutide) subcutaneous injection to improve glycemic control, along with diet and exercise, in adults with type 2 diabetes.
FDA Approves Topamax for Migraine Prevention in Adolescents
Today, the U.S. Food and Drug Administration approved Topamax (topiramate) for prevention (prophylaxis) of migraine headaches in adolescents ages 12 to 17. This is the first FDA approval of a drug for migraine prevention in this age group. The medication is taken on a daily basis to reduce the frequency of migraine headaches.
FDA Orders Wash.-based Smoked Seafood Manufacturer to Cease Operations
The U.S. Food and Drug Administration recently ordered Jensen’s Old Fashioned Smokehouse Inc., a processor of smoked fish products in Seattle, Wash., to stop processing, preparing, packing, holding and distributing any food at or from its facility.
FDA Approves Alprolix for Patients With Hemophilia B
The U.S. Food and Drug Administration today approved Alprolix, Coagulation Factor IX (Recombinant), Fc Fusion Protein, for use in adults and children who have Hemophilia B. Alprolix is the first Hemophilia B treatment designed to require less frequent injections when used to prevent or reduce the frequency of bleeding.
New Rx to Treat Tropical Disease
The U.S. Food and Drug Administration today approved Impavido (miltefosine) to treat a tropical disease called leishmaniasis.
FDA Approves New Device for Hearing Loss
The FDA has approved a new device that may help those with a specific kind of hearing loss who do not benefit from conventional hearing aids.