FDA issues Safety Alert on Intestinomicina
The US Food and Drug Administration is warning consumers not to use Intestinomicina, a drug product manufactured in El Salvador and marketed as a treatment for infectious diarrhea and acute gastrointestinal infections.
FDA releases preliminary data on arsenic levels in rice and rice products
As part of an ongoing and proactive effort to monitor food safety and address contaminants in food, the US Food and Drug Administration today released preliminary data on arsenic levels in certain rice and rice products.
FDA Issues Painkiller Safety Alert
Watson Laboratories, Inc. notified the public of a voluntary nationwide recall for two lots of Hydrocodone Bitartrate and APAP Tablets, USP 10 mg/500 mg (Lot Numbers 519406A and 521759A, both with the expiry date April 2014, distributed between 6/27/2012 and 7/18/2012 to wholesale distributors and retail pharmacies nationwide).
FDA issues warning letters to PruTect Rx and Trinity Sports Group Inc
The US Food and Drug Administration today issued warning letters to PruTect Rx, of Highlands Ranch, Colo., and Trinity Sports Group Inc., of Plano, Texas, for promoting products labeled as dietary supplements with claims to treat concussions and prevent or treat post-concussion syndrome and other neurological disorders.
FDA Approves Children's Brain Tumor Drug
The US Food and Drug Administration today approved Afinitor Disperz (everolimus tablets for oral suspension), a new pediatric dosage form of the anti-cancer drug Afinitor (everolimus) used to treat a rare brain tumor called subependymal giant cell astrocytoma (SEGA).
FDA Approves Breast Tissue Ultrasound
The US Food and Drug Administration approved the first ultrasound device for use in combination with a standard mammography in women with dense breast tissue who have a negative mammogram and no symptoms of breast cancer.
FDA Safety Alert on Intestinomicina
The US Food and Drug Administration is warning consumers not to use Intestinomicina, a drug product manufactured in El Salvador and marketed as a treatment for infectious diarrhea and acute gastrointestinal infections.
Generic Actos to Treat Type 2 Diabetes
The U.S. Food and Drug Administration (FDA) today approved the first generic version of Actos ( pioglitazone hydrochloride) tablets. Along with diet and exercise, pioglitazone is used to improve blood glucose control in adults with type 2 diabetes.
FDA Approves Generic Singulair
The US Food and Drug Administration approved the first generic versions of Singulair (montelukast sodium) for use in adults and children to control asthma symptoms and to help relieve symptoms of indoor and outdoor allergies.
FDA Approves New Vaccine for Children
Today the US Food and Drug Administration 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 Yand Haemophilus influenzae type b.