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Newsletter
Vol 71 - July 2010
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 16, 2010
Treatment for: Acne
Veltin 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
Date of Approval: June 30, 2010
Treatment for: Pain
Butrans 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.
FDA MedWatch Alerts
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News & Articles
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