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Featured News H1N1 Protection in Coming Season's Flu Vaccines: FDA
July 2010
The flu vaccines approved for the 2010-11 season protect against three strains of influenza, including the 2009 H1N1 pandemic swine flu strain, the United States Food and Drug Administration has announced. Read more... New Drug Approvals
The following drugs have recently been approved by the FDA. Date of Approval: July 28, 2010 Treatment for: Chronic Drooling in Children Cuvposa Drug Information | Press Release Date of Approval: July 23, 2010 Treatment for: Hypertension Tribenzor Drug Information | Press Release Date of Approval: July 2, 2010 Treatment for: Prevention of Chemotherapy-Induced, Radiotherapy-Induced, and Postoperative Nausea and Vomiting Zuplenz Drug Information | Press Release Date of Approval: July 1, 2010
Treatment for: Alpha-1 Proteinase Inhibitor Deficiency Glassia 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: July 28, 2010 Now Approved: 500 mg/40 mg and 1000 mg/40 mg Strengths Simcor Drug Information | Press Release New Dosage Form Approved: July 23, 2010 Now Approved: Aricept 23 mg Tablets Aricept Drug Information | Press Release Patient Population Altered: June 29, 2010
Now Approved for: Treatment of ADHD in Adolescents Daytrana 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.
Chlorzoxazone Tablets USP, 375 mg and 750 mg Approved: June 1, 2010 - Mikart Inc. Generic for: Parafon Forte DSC Caplets Adapalene Gel 0.1% Approved: June 2, 2010 - Pliva Hrvatska D.O.O. Generic for: Differin Gel Miconazole Nitrate Vaginal Insert & Miconazole Nitrate Cream 1200 mg/2% Approved: June 2, 2010 - Perrigo R&D Company Generic for: Monistat 1 Combination Pack Oxymorphone Hydrochloride Extended-Release Tablets 5 mg, 10 mg, 20 mg and 40 mg Approved: June 14, 2010 - Impax Laboratories, Inc. Generic for: Opana ER Tablets Articaine Hydrochloride and Epinephrine Injection 4%/1:100,000 (Dental Cartridge) Approved: June 18, 2010 - Hospira Inc. Generic for: Septocaine and Epinephrine Injection (4%/1:100,000) Meropenem for Injection USP, 500 mg/vial and 1 g/vial Approved: June 22, 2010 - Hospira, Inc. Generic for: Merrem I.V. for Injection Anastrozole Tablets 1 mg Approved: June 28, 2010 - Accord Healthcare Inc., USA; Natco Pharma Limited; Sandoz Inc.;Stason Pharmaceuticals, Inc.; Mylan Pharmaceuticals, Inc.; Zydus Pharmaceuticals USA, Inc.; Three Rivers Pharmaceuticals, LLC; Fresenius Kabi Oncology plc;Synthon Pharmaceuticals, Inc.; Roxane Laboratories, Inc.; Watson Laboratories, Inc.; Dr. Reddy's Laboratories, Ltd. Generic for: Arimidex Tablets Venlafaxine Hydrochloride Extended-Release Capsules 37.5 mg (base), 75 mg (base) and 150 mg (base) Approved: June 28, 2010 - Teva Pharmaceuticals USA Generic for: Effexor XR Capsules Adapalene Cream
0.1% Approved: June 30, 2010 - Nycomed US, Inc. Generic for: Differin Cream Other Drug News
Not All Epilepsy Drugs Raise Suicide Risk: Study July 26, 2010 Since 2008, the United States Food and Drug Administration has required that all epilepsy drugs bear a warning label about an increased risk of suicidal behaviors, but German doctors report that only certain medications may increase the risk of self-harm.
Stroke Prevention Treatment Varies Widely Across U.S. July 26, 2010 Doctors across the United States differ greatly in how they choose to open up clogged neck arteries to help prevent stroke, a new study shows.
Sunscreen Concerns Unfounded, Experts Say July 26, 2010 Recent reports questioning the safety of many sunscreens have experts worried that some people may shun the very products that could save their lives, not to mention their skin.
Avoid Mosquito Bites to Prevent Dengue Fever in Florida: Expert July 23, 2010 People planning to visit Florida should take measures to protect themselves against dengue fever by preventing mosquito bites, advises an expert.
Giving Kids Booze, Medicines Can Be Child Abuse July 22, 2010 The malicious use of alcohol and medicines is an under-recognized form of child abuse, according to a new report.
Moderate Caffeine Intake Safe During Pregnancy, Experts Say July 21, 2010 Women can drink a cup of coffee or one soft drink a day during pregnancy and not worry that it might put them at risk of miscarriage or preterm birth, according to new guidelines released by the American College of Obstetricians and Gynecologists.
Researchers Use Ecstasy to Treat PTSD July 19, 2010 A small study suggests that the illicit "club drug" Ecstasy may have one positive use: making psychotherapy more effective for people with post-traumatic stress disorder (PTSD).
More Americans Abusing Prescription Painkillers July 15, 2010 Substance abuse treatment admissions for non-medical use of prescription pain relievers have increased more than 400 percent over 10 years, according to a new government study.
Diabetics Urged to Confer With Their Doctor About Avandia Use July 15, 2010 One day after a United States advisory panel recommended that the controversial diabetes drug Avandia stay on the market - albeit with added restrictions - several medical organizations are urging patients not to change their medications before consulting a health-care professional.
Experts Issue New Guidelines on Breast Cancer Drugs July 13, 2010 A leading group of cancer experts has issued new guidelines on the best way to use two classes of hormone therapies for estrogen receptor-positive breast cancer, the most common form of breast tumor.
Antibiotic May Up Risk of Dangerous Potassium Levels in Seniors
July 1, 2010 A new study warns that seniors who take a common antibiotic combination for urinary tract infections are at increased risk of developing potentially life-threatening high potassium levels. |
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