Updated FDA Statement on Compounded Versions of hydroxyprogesterone caproate (the active ingredient in Makena)

The U.S. Food and Drug Administration today approved Menhibrix, a combination vaccine for infants and children ages 6 weeks through 18 months, for prevention of invasive disease caused by Neisseria meningitidis serogroups C and Y and Haemophilus influenzae type b.

The U.S. Food and Drug Administration is urging food distributors, retailers, and food service operators to remove from sale or service all fresh, frozen, canned, and processed oysters, clams, mussels, and whole and roe-on scallops (molluscan shellfish) from Korea that have entered the United States. This includes molluscan shellfish from Korea that entered the United States prior to May 1, 2012, when the FDA removed such products from the Interstate Certified Shellfish Shippers List (ICSSL), and that which may have inadvertently entered the country after that date. These products and any products made with them may have been exposed to human fecal waste and are potentially contaminated with norovirus.

The U.S. Food and Drug Administration today approved Perjeta (pertuzumab), a new anti-HER2 therapy, to treat patients with HER2-positive late-stage (metastatic) breast cancer.

On May 31, 2012, at the request of the U.S. Food and Drug Administration, U.S. Marshals seized drug products from Global Biotechnologies, Inc., of Portland, Maine, pursuant to a warrant issued by the U.S. District Court for the District of Maine.

Health officials in Mexico order recall based on potentially harmful pharmaceutical ingredients in Reuofan Plus. The U.S. Food and Drug Administration is warning consumers that Reumofan Plus, marketed as a “natural� dietary supplement for pain relief and other serious conditions, contains several active pharmaceutical ingredients not listed on the label that could be harmful.

The U.S. Food and Drug Administration is warning consumers and health care professionals about a counterfeit version of Teva Pharmaceutical Industries’ Adderall 30 milligram tablets that is being purchased on the Internet. Adderall, which is approved to treat attention deficit hyperactivity disorders (ADHD) and narcolepsy, is a prescription drug classified as a controlled substance, a class of drugs for which special controls are required for dispensing by pharmacists.

The U.S. Food and Drug Administration is warning consumers and health care professionals about a counterfeit version of Teva Pharmaceutical Industries’ Adderall 30 milligram tablets that is being purchased on the Internet. Adderall, which is approved to treat attention deficit hyperactivity disorders (ADHD) and narcolepsy, is a prescription drug classified as a controlled substance – a class of drugs for which special controls are required for dispensing by pharmacists.

U.S. Marshals, acting at the request of the Food and Drug Administration, have seized HybriSil (methylprednisolone acetate 1% percentin silicone gel), an unapproved new drug marketed by Crescendo Therapeutics, L.L.C., of Vista, Calif.

A team of researchers led by the U.S. Food and Drug Administration has discovered a new mechanism for identifying and understanding drug-related autoimmune reactions.