FDA Alerts
FDA Approves Jetrea For Eye Disease
The US Food and Drug Administration approved Jetrea (ocriplasmin), the first drug approved to treat an eye condition called symptomatic vitreomacular adhesion (VMA).
FDA Warning: Serious Adverse Events From Eye Drops and Nasal Sprays Ingestion
The US Food and Drug Administration (FDA) is warning the public that accidental ingestion (swallowing) by children of over-the-counter (OTC; available without a prescription) eye drops used to relieve redness and nasal decongestant sprays can result in serious harm.
FDA Approves Xeljanz For Rheumatoid Arthritis
The US Food and Drug Administration approved Xeljanz ( tofacitinib ) to treat adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to, or who are intolerant of, methotrexate .
FDA Warns Tennessee Company that Online Product Claims Violate Federal Law
The US Food and Drug Administration today issued a Warning Letter to The Avalon Effect Inc., a company based in Franklin, Tenn., for its marketing of a light therapy product that claims to cure or treat symptoms of fungal meningitis, methicillin-resistant Staphylococcus aureus (MRSA), concussions, Lyme disease, and other diseases.
FDA expands use of Xarelto to treat, reduce recurrence of blood clots
The US Food and Drug Administration today expanded the approved use of Xarelto (rivaroxaban) to include treating deep vein thrombosis (DVT) or pulmonary embolism (PE), and to reduce the risk of recurrent DVT and PE following initial treatment.
FDA Reports Voluntary Recall of all Ameridose Drug Products
The US Food and Drug Administration announced today that Ameridose, LLC, based in Westborough, Mass., is voluntarily recalling all of its unexpired products in circulation.
Synribo for Chronic Myelogenous Leukemia Approved by FDA
The US Food and Drug Administration today approved Synribo (omacetaxine mepesuccinate) to treat adults with chronic myelogenous leukemia (CML), a blood and bone marrow disease.
FDA Approves Humira to Treat Ulcerative Colitis
The U.S. Food and Drug Administration today expanded the approved use of Humira ( adalimumab ) to include treatment of moderate-to-severe ulcerative colitis in adults.
FDA approves new treatment for advanced colorectal cancer
The US Food and Drug Administration today approved Stivarga (regorafenib) to treat patients with colorectal cancer that has progressed after treatment and spread to other parts of the body (metastatic).
FDA Drug Safety Communication: Mirapex and Heart Failure
The US Food and Drug Administration (FDA) is informing the public about a possible increased risk of heart failure with Mirapex (pramipexole), a drug used to treat Parkinson’s disease and restless legs syndrome.