FDA
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FDA Approves New Multiple Sclerosis Capsules
March 28, 2013 8:10 am | News | Comments
The U.S. Food and Drug Administration said Wednesday it approved a new drug from Biogen Idec to control multiple sclerosis in adults with hard-to-treat forms of the disease.The twice-a-day capsules, called Tecfidera, offer a new option for multiple sclerosis, a debilitating disease in which the body attacks its own nervous system.
FDA Approves New Multiple Sclerosis Capsules
March 28, 2013 8:10 am | News | Comments
The U.S. Food and Drug Administration said Wednesday it approved a new drug from Biogen Idec to...
Clinical Specialties Compounding Pharmacy Recalling All Lots of Sterile Products
March 21, 2013 8:22 am | News | Comments
Clinical Specialties is voluntarily recalling All Lots of All Sterile products repackaged and...
Medprep Consulting Recalls All Lots of Magnesium Sulfate 2gm In Dextrose 5% In Water, 50ml For Injection
March 18, 2013 8:04 am | News | Comments
The level of recall is to the user, that is, regional hospital pharmacies and related...
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FDA Has Safety Concerns with Merck Insomnia Drug
May 20, 2013 11:42 am | by MATTHEW PERRONE - AP Health Writer - Associated Press | News | CommentsFederal health regulators say an experimental insomnia drug from Merck can help patients fall asleep, but it also carries worrisome side effects, including daytime drowsiness and suicidal thinking. The Food and Drug Administration on Monday released its review of the company's sleep aid,...
FDA Unveils a New Tool to Fight Counterfeit Products
May 17, 2013 8:54 am | Videos | CommentsCD-3 is a new tool in the Food and Drug Administration’s fight against counterfeit products. CD-3 is a low-cost, portable tool that uses light to detect counterfeit products. CD-3 can be deployed anywhere and is helping the FDA protect consumers.
FDA Tobacco Chief Speaks at Industry Meeting
May 17, 2013 8:10 am | by MICHAEL FELBERBAUM,AP Tobacco Writer | News | CommentsChanges in the marketplace have forced the public health community to wrestle with the idea that some tobacco products may pose less of a health risk than others, the new head of the Food and Drug Administration's tobacco control efforts told an industry group on Thursday.
Oramed Receives FDA Clearance to Initiate Oral Insulin Trials in the U.S.
May 17, 2013 7:57 am | News | CommentsOramed Pharmaceuticals Inc. a developer of oral drug delivery systems, announced today that the United States Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug application(IND) for ORMD-0801, its oral insulin capsule.
US Approves Radiation-Based Prostate Cancer Drug
May 16, 2013 8:28 am | News | CommentsThe U.S. Food and Drug Administration has approved a new injectable drug that uses radiation to treat advanced prostate cancer that has spread to the bones. The FDA said Wednesday it approved the drug, Xofigo from Bayer Pharmaceuticals, for men whose cancer has grown into bone tumors even after receiving medication or surgery to lower testosterone.
SIMPONI Receives FDA Approval for Ulcerative Colitis
May 16, 2013 8:17 am | News | CommentsJanssen Biotech, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved SIMPONI (golimumab) for the treatment of moderately to severely active ulcerative colitis (UC) in adult patients who have demonstrated corticosteroid dependence or who have had an inadequate response to or failed to tolerate oral aminosalicylates, oral corticosteroids, azathioprine, or 6-mercaptopurine.
FDA Recommends Lower Dosage of Ambien
May 15, 2013 8:39 am | Videos | CommentsThose who take products containing zolpidem, best know by the drug’s brand name Ambien, are now being advised by the Food and Drug Administration to take less of the medication. Patients who take the drug, especially the extended release version, are advised not to drive the next day as levels of the drug remain high in the body
Study Questions How Sharply US Should Cut the Salt
May 15, 2013 8:19 am | by LAURAN NEERGAARD,AP Medical Writer | News | CommentsA surprising new report questions public health efforts to get Americans to sharply cut back on salt, saying it's not clear whether eating super-low levels is worth the struggle. Make no mistake: Most Americans eat way too much salt, not just from salt shakers but because of sodium hidden inside processed foods and restaurant meals.
ADCETRIS Supplemental BLA Accepted for Filing by the FDA
May 14, 2013 9:19 am | News | CommentsSeattle Genetics, Inc. announced that the FDA has accepted for filing a supplement to the Biologics License Application supporting the use of ADCETRIS for retreatment and extended duration beyond 16 cycles of therapy in relapsed Hodgkin lymphoma and systemic anaplastic large cell lymphoma.
FDA Accepts Biogen Idec’s BLA for Long-Lasting Factor VIII Therapy for Hemophilia A
May 13, 2013 8:31 am | News | CommentsBiogen Idec announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) for the marketing approval of ELOCTATE™ (recombinant factor VIII Fc fusion protein) for the treatment of hemophilia A.
FDA Denies Request to Block Generic Painkiller
May 10, 2013 5:53 pm | by The Associated Press | News | CommentsIn a surprise move Friday, federal health regulators denied a request by Endo Health Solutions to block generic versions of its painkiller Opana ER, which the company argued are more easily abused than its branded product. Endo's Opana ER is a long-acting narcotic drug used to treat moderate and...
State Pharmacy Boards Back More FDA Oversight
May 9, 2013 3:00 pm | by MATTHEW PERRONE,AP Health Writer | News | CommentsState pharmacy officials on Thursday threw their support behind a proposal giving the Food and Drug Administration authority over large compounding pharmacies, in an effort to head off more outbreaks tied to contaminated medications. The head of the National Association of Boards of Pharmacy told Senate lawmakers that his group welcomes FDA action against pharmacies like the one that triggered a deadly meningitis outbreak last year.
Merck: FDA Reviewing its Ragweed Allergy Therapy
May 8, 2013 12:47 pm | by The Associated Press | News | CommentsWHITEHOUSE STATION, N.J. (AP) — Drugmaker Merck & Co. says the Food and Drug Administration is reviewing its second application to sell a new type of allergy treatment meant to gradually reduce allergic reactions over time, rather than just relieving sneezing, itching and other symptoms...
Ariad Reports $6.4M in First Quarter Sales of Leukemia Pill
May 8, 2013 8:13 am | News | CommentsAriad Pharmaceuticals Inc. said Tuesday that revenue from its leukemia pill Iclusig, its first approved drug, totaled $6.4 million in the first quarter, surpassing Wall Street's expectations. The Food and Drug Administration approved Iclusig in December as a treatment for two types of the disease.
Cubist Antibiotic Regimen Gets Fast-Track Review
May 8, 2013 8:10 am | News | CommentsCubist Pharmaceuticals Inc. said Tuesday that the Food and Drug Administration has given fast-track status to an experimental antibiotic regimen as a treatment for three types of infections. The company is studying a combination of ceftolozane and tazobactam as a treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia as well as complicated urinary-tract infections.
FDA Wants Cancer Warnings on Tanning Beds
May 7, 2013 8:24 am | by MATTHEW PERRONE,AP Health Writer | News | CommentsIndoor tanning beds would come with new warnings about the risk of cancer and be subject to more stringent federal oversight under a proposal unveiled Monday by the Food and Drug Administration. The FDA has regulated tanning beds and sun lamps for over 30 years, but for the first time ever the agency says those devices should not be used by people under age 18.
FDA Warns Pregnant Women of Migraine Drug Risk
May 7, 2013 8:17 am | by MATTHEW PERRONE,AP Health Writer | News | CommentsU.S. health regulators are warning doctors and women of child-bearing age that half-a-dozen medications used to treat migraine headaches can decrease children's intelligence if taken while their mothers are pregnant. The Food and Drug Administration said Monday that the drugs, including Depakote and Depacon, should never be taken by pregnant women for the prevention of migraine headaches.
FDA Approves Merck Combination Cholesterol Pill
May 3, 2013 5:56 pm | by The Associated Press | News | CommentsWHITEHOUSE STATION, N.J. (AP) — Merck & Co. said Friday that it received U.S. marketing approval for the new combination cholesterol drug Liptruzet, which combines the company's drug Zetia with a generic version of the mega-blockbuster drug Lipitor. The Food and Drug Administration approved...
FDA OKs Bristol's HIV Drug for Younger Patients
May 3, 2013 5:51 pm | by The Associated Press | News | CommentsBristol-Myers Squibb Co. said Friday that U.S. regulators expanded approval of its HIV drug Sustiva to children as young as three months old. The capsule-based drug was first approved in 1998 to treat HIV-infected children who are age three and older and weigh at least 22 pounds. The new approval...
FDA Reviewing Chemical Found in Soap
May 3, 2013 8:37 am | Videos | CommentsThe FDA is reviewing whether triclosan, an antibacterial contained in liquid soap and body wash may be ineffective or even harmful to humans. Recent studies on animals have shown an increased risk of infertility, early puberty and other hormonal issues.
FDA Approves Bristol-Myers Squibb’s sNDA for Use of SUSTIVA® (efavirenz) in HIV-1 Infected Pediatric Patients
May 3, 2013 8:32 am | News | CommentsBristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for SUSTIVA ® (efavirenz), including dosing recommendations for HIV-1 infected pediatric patients three months to three years old and weighing at least 3.5 kg.
Hyperion Therapeutics Drug Gets FDA Orphan Status
May 3, 2013 8:20 am | News | CommentsHyperion Therapeutics Inc. said Thursday that its drug Ravicti received orphan drug status, giving the drug seven years of marketing exclusivity. Ravicti was approved Feb. 1 as a treatment for urea cycle disorders, a rare type of enzyme deficiency, in patients 2 years and older. The Food and Drug Administration's decision to grant orphan drug status will keep similar products off the market until Feb. 1, 2020.
Decades-Old Question: Is Antibacterial Soap Safe?
May 3, 2013 8:04 am | by MATTHEW PERRONE,AP Health Writer | News | CommentsIt's a chemical that's been in U.S. households for more than 40 years, from the body wash in your bathroom shower to the knives on your kitchen counter to the bedding in your baby's basinet. But federal health regulators are just now deciding whether triclosan — the germ-killing ingredient found in an estimated 75 percent of antibacterial liquid soaps and body washes sold in the U.S. — is ineffective, or worse, harmful.
Alimera Sciences Announces New PDUFA Date For ILUVIEN
May 1, 2013 8:54 am | News | CommentsAlimera Sciences, Inc. announced that its recent resubmission of the New Drug Application for ILUVIEN@ has been acknowledged as received by the FDA as a complete class 2 response to the FDA's November 2011 letter and that a new Prescription Drug User Fee Act goal date of October 17, 2013 has been established.
Teva's Plan B to Move Over-the-Counter
May 1, 2013 8:39 am | News | CommentsThe FDA announced on Tuesday that it lowered to 15 the age at which women can buy Teva’s Plan B One-Step (levonorgestrel) emergency oral contraceptive and also allowed the drug to be available over-the-counter without a prescription. Previously, only those aged 17 or older could obtain the emergency oral contraceptive without a prescription.
