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Featured News Monthly News Round Up - July 2012
July 2012
Vascepa Approved for Treatment of Severely High Triglyceride Levels The U.S. Read more... New Drug Approvals
The following drugs have recently been approved by the FDA. Date of Approval: July 26, 2012 Treatment for: Rheumatoid Arthritis, Polymyalgia Rheumatica, Psoriatic Arthritis, Ankylosing Spondylitis, Asthma, Chronic Obstructive Pulmonary Disease Rayos Drug Information | Press Release Date of Approval: July 26, 2012 Treatment for: Hypertriglyceridemia Vascepa Drug Information | Press Release Date of Approval: July 23, 2012 Treatment for: Chronic Obstructive Pulmonary Disease Tudorza Drug Information | Press Release Date of Approval: July 20, 2012 Treatment for: Multiple Myeloma Kyprolis Drug Information | Press Release Date of Approval: July 16, 2012
Treatment for: Bowel Preparation Prepopik 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 Indication Approved: July 20, 2012 Now Approved for: Advanced Breast Cancer Afinitor Drug Information | Press Release New Indication Approved: July 16, 2012
Now Approved for: Reducing the Risk of Sexually Acquired HIV Infection Truvada 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.
Pregabalin Capsules 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg Approved: July 3, 2012 - Lupin Pharmaceuticals, Inc., Watson Pharmaceuticals, Inc., Teva Pharmaceuticals USA, Inc. Generic for: Lyrica Diclofenac Sodium and Misoprostol Delayed Release Tablets 50 mg/0.2 mg and 75 mg/0.2 mg Approved: July 9, 2012 - Watson Pharmaceuticals, Inc. Generic for: Arthrotec Levonorgestrel Tablets (Next Choice One Dose) 1.5 mg Approved: July 12, 2012 - Watson Pharmaceuticals, Inc. Generic for: Plan B One-Step Modafinil Tablets 100 mg and 200 mg Approved: July 16, 2012 - Mylan Pharmaceuticals, Inc. Generic for: Provigil Entacapone Tablets 200 mg Approved: July 16, 2012 - Sun Pharma Global Generic for: Comtan Fexofenadine Hydrochloride Oral Suspension
30 mg/5 mL Approved: July 25, 2012 - Actavis Mid Atlantic Generic for: Allegra Oral Suspension FDA Drug Safety Labeling Changes
This is a summary of the FDA drug labeling changes for May 2012. 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
Two New Weight-Loss Drugs Won't Reverse U.S. Obesity Crisis July 19, 2012 The U.S. Food and Drug Administration's approval of two new weight-loss drugs within the past month - the first such medications in 13 years - won't be a panacea for America's obesity epidemic, health professionals say.
Top 100 Drug Sales Data Released - Plavix Leads the Way July 18, 2012 Drugs.com Stats Center Lists the Top 100 Drugs Q1 2012 in the United States.
Guidelines Issued for New Blood Thinner Brilinta July 16, 2012 The new blood-thinning drug Brilinta should be considered along with older drugs to treat patients with unstable angina, according to updated guidelines.
Aging Boomers' Mental Health Woes Will Swamp Health System: Report July 10, 2012 The United States faces an unprecedented number of aging baby boomers with mental health or substance use issues, a number so great it could overwhelm the existing health care system, a new report warned Tuesday.
Teach Prescribers About Dangers of Long-Acting Pain Meds: FDA July 9, 2012 As part of its efforts to curb the abuse of narcotic painkillers, the FDA is requiring drug makers to educate doctors about the risks of long-acting and extended-release forms of the drugs.
New Test Helps Evaluate Cancer Drug's Merit July 9, 2012 A new genetic test to help doctors determine if the drug Erbitux would be an effective treatment for certain colorectal cancer patients has been approved by the Food and Drug Administration.
More Proof Cranberry Juice Thwarts Infection July 9, 2012 Cranberry juice and cranberry supplements really do help prevent urinary tract infections, a new study confirms.
Medical Groups Agree on Use of Hormone-Replacement Therapy July 9, 2012 A coalition of leading medical groups has concluded that hormone-replacement therapy can be useful and safe for many women suffering from the symptoms of menopause.
HPV Vaccine Reducing Infections, Even Among Unvaccinated: Study July 9, 2012 Even among unvaccinated girls and young women, the human papillomavirus vaccine is reducing infections of certain strains of the virus known to cause genital warts and cervical cancer, new research finds.
Methadone for Pain Relief Leading Cause of Fatal Overdoses: CDC July 3, 2012 Although methadone accounts for only 2 percent of the painkiller prescriptions in the United States, it is tied to more than 30 percent of painkiller overdose deaths, according to a government report released Tuesday.
Half of Heart Patients Make Mistakes With Their Meds: Study July 3, 2012 Half of patients hospitalized for a heart attack or heart failure will make a mistake with their medications within a month of checking out of the hospital, new research shows.
First Over-the-Counter HIV Test Approved July 3, 2012 The first over-the-counter test to detect antibodies to the virus that causes AIDS has been approved by the Food and Drug Administration, the agency said Tuesday. |
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