The U.S. Food and Drug Administration today unveiled a new strategy to meet the challenges posed by rapidly rising imports of FDA-regulated products and a complex global supply chain in a report called the “Pathway to Global Product Safety and Quality.”
Category Archives: Drug Recalls & Safety Notices
FDA approves first generic versions of the antibiotic levofloxacin to treat certain infections
The U.S. Food and Drug Administration today approved the first generic versions of Levaquin (levofloxacin), an antibiotic approved to treat certain infections in people ages 18 and older.
Levofloxacin is used to treat mild, moderate, or severe bacterial infections of the skin, sinuses, kidneys, bladder, and prostate caused by specific germs. It also is used to treat certain bacterial infections that cause bronchitis or pneumonia, and to treat those exposed to inhalational anthrax.
FDA: California seafood handler enters into consent decree
The U.S. Food and Drug Administration and San Diego-based Ocean Harvest Inc., an outlet for salmon, tuna, and other fresh fish intended for raw consumption, and Ocean Harvest president, Minkyu Park, recently signed a consent decree of permanent injunction. The company had been selling seafood that was handled in violation of federal food safety standards.
FDA approves Nulojix for kidney transplant patients
The U.S. Food and Drug Administration today approved Nulojix (belatacept) to prevent acute rejection in adult patients who have had a kidney transplant. The drug is approved for use with other immunosuppressants (medications that suppress the immune system) — specifically basiliximab, mycophenolate mofetil, and corticosteroids.
FDA approves new test to help determine if breast cancer patients are candidates for Herceptin treatment
The U.S. Food and Drug Administration today approved a new genetic test that will help health care professionals determine if women with breast cancer are HER2-positive and, therefore, candidates for Herceptin (trastuzumab), a commonly used breast cancer treatment.
FDA approves first ceramic-on-metal total hip replacement system
The U.S. Food and Drug Administration approved on June 13 the first ceramic-on-metal total artificial hip system for patients with osteoarthritis.
FDA Announces Changes to Better Inform Consumers About Sunscreen
New Rules Give Consumers More Information to Help Reduce the Risk of Skin Cancer, Early Aging
Federal government takes action against drug manufacturer and distributor
H&P Industries, Triad Group, and company officers agree to correct deficiencies
FDA approves Potiga to treat seizures in adults
On June 10, Potiga (ezogabine) tablets were approved by the U.S. Food and Drug Administration for use as an add-on medication to treat seizures associated with epilepsy in adults.
Potiga was approved for the treatment of partial seizures, the most common type of seizure seen in people with epilepsy.
FDA approves redesigned labels for some Merck drugs
The U.S. Food and Drug Administration today is announcing the approval of Merck’s redesigned drug container labels that include a new standardized format to improve readability and provide better information on product and strength differentiation.