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Featured News Monthly Roundup - August 2011
August 2011
Two Targeted Therapies Approved: Xalkori and Zelboraf for Aggressive Cancers Two advanced cancer treatments with accompanying diagnostic genetic tests have been approved this month. Read more... New Drug Approvals
The following drugs have recently been approved by the FDA. Date of Approval: August 26, 2011 Treatment for: Non-Small Cell Lung Cancer Xalkori Drug Information | Press Release Date of Approval: August 19, 2011 Treatment for: Lymphoma, Hodgkin's Disease Adcetris Drug Information | Press Release Date of Approval: August 17, 2011 Treatment for: Melanoma - Metastatic Zelboraf Drug Information | Press Release Date of Approval: August 10, 2011 Treatment for: HIV Infection Complera Drug Information | Press Release Date of Approval: August 3, 2011
Treatment for: Scorpion Stings Anascorp Drug Information | Press Release New Indications and Dosage Forms
Drugs that have gained FDA approval for the treatment of additional diseases/conditions or new dosage forms/regimens. New Dosage Form Approved: August 25, 2011 Now Approved: Nucynta ER Nucynta Drug Information | Press Release New Indication Approved: August 24, 2011
Now Approved for: Urinary Incontinence Botox Drug Information | Press Release First-Time Generic Approvals
First Time Generics are those drug products that have never been approved before as generic drug products and are new generic products to the marketplace.
Fondaparinux Sodium Injection 2.5 mg/0.5 mL, 5 mg/0.4 mL, 7.5 mg/0.6 mL and 10 mg/0.8 mL Approved: July 11, 2011 - Dr. Reddy's Laboratories Limited Generic for: Arixtra
Alfuzosin Hydrochloride Extended-Release Tablets 10 mg Approved: July 18, 2011 - Apotex Inc.; Mylan Pharmaceuticals, Inc.; Torrent Pharmaceuticals; Teva Pharmaceuticals USA; Sun Pharmaceutical Industries Limited Generic for: Uroxatral
Metronidazole Topical Gel 1% Approved: July 22, 2011 - Tolmar, Inc. Generic for: Metrogel 1%
Phentermine Resin Complex Extended-Release Capsules
15 mg (base) and 30 mg (base) Approved: July 28, 2011 - Lannett Company, Inc. Generic for: Ionamin FDA Drug Safety Labeling Changes
This is a summary of the FDA drug labeling changes for July 2011. Click on a drug name to view the changes in more detail.
Note: the drug safety labeling changes listed above may not be a complete list. Please visit the link below for the entire current list and historical archive.
Other Drug News
HPV Vaccination Rates Low Among Teen Girls, CDC Reports August 25, 2011 Teen vaccination rates for human papillomavirus (HPV) are lagging behind rates for two other important vaccines in the United States, federal researchers say.
U.S.-Mandated Report Finds Vaccines Safe for Kids August 25, 2011 An exhaustive new report from experts at the Institute of Medicine finds that children's vaccines are typically safe, with bad reactions occurring only rarely and then not causing any lasting medical problems.
Mainstay Meds Often Cut Off Accidentally After Hospital Stay August 23, 2011 Many patients who are hospitalized fail to receive their regular medications for chronic conditions during their stay and often fail to restart them when they're discharged, researchers say.
Excessive Heat Can Harm Medications, Expert Says August 20, 2011 Medications can be harmed by high temperatures, say pharmacists.
Don't Skip This Year's Flu Shot: CDC August 18, 2011 The 2011-12 flu vaccine protects against seasonal flu and H1N1, just like last year's, but that doesn't mean it's OK to skip your yearly flu shot, researchers from the Centers for Disease Control and Prevention warn.
Kids Benefit From Flu Vaccine via Shot or Spray, Study Finds August 18, 2011 Children younger than 3 years old receive roughly the same amount of protection from the flu vaccine regardless of which method (injection, nasal spray, or one of each) is used to give the two recommended doses to them, according to a new federal study.
New Uses Found for Old Drugs August 17, 2011 Many drugs already approved to combat certain illnesses may also be helpful in treating a slew of other seemingly unrelated health problems, a new study indicates.
Antipsychotics Best for Controlling Mania: Study August 16, 2011 The manic episodes experienced by those with bipolar disorder are better controlled by antipsychotic drugs than mood stabilizers, a new, large study suggests.
U.S. Women Using Dangerous Weight-Loss Pill 2 Years After Recall August 16, 2011 Many women in the United States continue to use a Chinese weight-loss supplement that's been recalled due to dangerous ingredients, a new study indicates.
Patients Taking Antipsychotics Urged to Get Routine Physicals August 12, 2011 Patients who take antipsychotic medications aren't being adequately monitored for dangerous health complications, researchers have found.
Depression Linked to Increased Risk of Stroke in Women August 12, 2011 Depressed women may face an increased risk of stroke, according to new research reported in Stroke: Journal of the American Heart Association.
Americans' Use of Antidepressants On the Rise: Study August 4, 2011 Americans are popping more antidepressants than ever before to deal with everyday stress, and non-psychiatrists are increasingly willing to prescribe the drugs to patients with no mental health diagnosis, a new study finds.
Popular Antidepressants Not Always Best Choice for Seniors August 2, 2011 New research suggests that hugely popular antidepressants such as Prozac and Effexor might not always be the best choice for seniors, since they seem to have more side effects than older antidepressants do. |
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