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Featured News Monthly News Round Up - August 2012
August 2012
Xtandi Receives Priority Review Approval for Late Stage Prostate Cancer Roughly 28,000 men will die from prostate cancer in 2012. Read more... New Drug Approvals
The following drugs have recently been approved by the FDA. Date of Approval: August 31, 2012 Treatment for: Prostate Cancer Xtandi Drug Information | Press Release Date of Approval: August 30, 2012 Treatment for: Irritable Bowel Syndrome, Constipation -- Chronic Linzess Drug Information | Press Release Date of Approval: August 29, 2012 Treatment for: Neutropenia Associated with Chemotherapy tbo-filgrastim Drug Information | Press Release Date of Approval: August 27, 2012 Treatment for: HIV Infection Stribild Drug Information | Press Release Date of Approval: August 10, 2012 Treatment for: Anaphylaxis, Allergic Reaction Auvi-Q Drug Information | Press Release Date of Approval: August 9, 2012 Treatment for: Acute Lymphoblastic Leukemia Marqibo Drug Information | Press Release Date of Approval: August 3, 2012
Treatment for: Colorectal Cancer Zaltrap 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. Labeling Revision Approved: August 13, 2012 Now Approved for: Add-On Therapy to Insulin in Adults with Type 2 Diabetes Tradjenta Drug Information | Press Release New Dosage Form Approved: August 27, 2012 Now Approved Exaglo 32 mg Extended-Release Tablets Exalgo Drug Information | Press Release New Dosage Form Approved: August 29, 2012 Now Approved: Afinitor Disperz Tablets for Oral Suspension Afinitor Drug Information | Press Release New Formulation Approved: August 10, 2012 Now Approved: Suboxone Sublingual Film 4 mg and 12 mg Suboxone Drug Information | Press Release New Indication Approved: August 28, 2012 Now Approved: Nucynta ER for Neuropathic Pain Associated With Diabetic Peripheral Neuropathy Nucynta Drug Information | Press Release New Indication Approved: August 10, 2012
Now Approved for: Diabetic Macular Edema Lucentis 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.
Montelukast Sodium Tablets 10 mg (base) Approved: August 3, 2012 - Apotex Inc.; Aurobindo Pharma; Endo Pharmaceuticals; Glenmark Generics; Kudco Ireland Inc.; Mylan Inc.; Roxane Laboratories; Sandoz Inc.; Teva Pharmaceuticals Inc.; Torrent Pharmaceuticals Generic for: Singulair Tablets Montelukast Sodium Chewable Tablets 4 mg (base) and 5 mg (base) Approved: August 3, 2012 - Apotex Inc.; Aurobindo Pharma; Endo Pharmaceuticals; Kudco Ireland Inc.; Mylan Inc.; Roxane Laboratories; Sandoz Inc.; Teva Pharmaceuticals Inc.; Torrent Pharmaceuticals Generic for: Singulair Chewable Tablets Montelukast Sodium Granules 4 mg (base)/packet Approved: August 3, 2012 - Teva Pharmaceuticals Inc. Generic for: Singulair Granules Didanosine Chewable Tablets 100 mg, 150 mg and 200 mg Approved: August 14, 2012 - Aurobindo Pharma Limited Generic for: Videx Chewable Tablets Pioglitazone Hydrochloride Tablets 15 mg (base), 30 mg (base) and 45 mg (base) Approved: August 17, 2012 - Mylan Pharmaceuticals Inc. Generic for: Actos Nedocromil Sodium Ophthalmic Solution 2% Approved: August 22, 2012 - Akorn, Inc. Generic for: Alocril Lidocaine Topical Patch
5% Approved: August 23, 2012 - Watson Pharmaceuticals, Inc. Generic for: Lidoderm FDA Drug Safety Labeling Changes
This is a summary of the FDA drug labeling changes for July 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
Breast Cancer Drug May Harm the Heart More Than Thought August 30, 2012 Women with breast cancer who are treated with the cancer drug Herceptin may have more long-term cardiac problems than experts have thought, new research suggests.
'Alarming' Rise Seen in Drug-Resistant Tuberculosis August 30, 2012 There are alarmingly high levels of extensively drug-resistant tuberculosis in many areas of the world, a new study finds.
Adding Plavix to Aspirin Doesn't Help Guard Against Second Stroke: Study August 29, 2012 Adding the clot-busting drug Plavix to a daily dose of aspirin is no better than taking aspirin alone to prevent a second stroke in people who have had a type of stroke that is typically caused by chronic high blood pressure, a new study shows.
Stopping Controversial Asthma Drugs Could Have Downside: Study August 27, 2012 It's okay for some patients with asthma to stick with a combination of medications instead of abandoning one because of concerns about complications, a new analysis of existing research suggests.
Newer Psoriasis Drugs May Lower Heart Attack Risk for Patients August 20, 2012 People with psoriasis who take a new class of drugs known as tumor necrosis factor (TNF) inhibitors may be at a lower risk for heart attack than their counterparts who only use topical medications to treat this inflammatory skin condition, a new study shows.
Vaccinations Belong on Parents' Back-to-School Checklists August 20, 2012 Vaccinations among school-aged children can save lives and parents should be sure their children are fully immunized as part of their back-to-school preparations, according to a pediatric infectious disease specialist.
FDA Warns of Risk of Death from Codeine Use in Some Children Following Surgeries
August 15, 2012 The U.S. Food and Drug Administration today issued a Drug Safety Communication concerning three children who died and one child who experienced a non-fatal but life-threatening case of respiratory depression after taking the pain reliever codeine following surgery to remove tonsils (tonsillectomy) and/or adenoids (adenoidectomy).
Older Antipsychotics May Work as Well as Newer Ones: Review August 14, 2012 Newer, more expensive schizophrenia medications are not noticeably better than their older, cheaper counterparts, a new review suggests.
Drug May Aid People With Advanced Thyroid Cancer August 13, 2012 A new study shows that the chemotherapy drug vandetanib (Caprelsa) may extend life a bit for some thyroid cancer patients.
FDA Approves Vaccines for the 2012-2013 Influenza Season August 13, 2012 The U.S. Food and Drug Administration announced today that it has approved the 2012-2013 influenza (flu) vaccine formulation for all six manufacturers licensed to produce and distribute the vaccines in the United States.
TB Vaccine Promising as New Way to Fight Type 1 Diabetes August 8, 2012 A small trial of a vaccine already approved for tuberculosis found that the vaccine can kill the rogue autoimmune cells that are active players in type 1 diabetes.
New Pill Might Relieve Severe Rheumatoid Arthritis August 8, 2012 A new oral medication may be available soon for people with rheumatoid arthritis who have not gained relief from other medicines.
New Vaccine May Offer Protection From Deadly Nipah Virus August 8, 2012 A new vaccine developed by a team of researchers may protect people and livestock from the deadly Nipah virus.
More Kids Taking Antipsychotics for ADHD: Study August 7, 2012 Use of powerful antipsychotic medications such as Abilify and Risperdal to control youngsters with attention-deficit/hyperactivity disorder (ADHD) and other behavior problems has skyrocketed in recent years, a new study finds.
Breast Cancer Drug Duo Wins Out in Study August 1, 2012 A combination of two cancer drugs works better than one alone to improve survival in older women with a type of breast cancer that has spread, new research suggests. |
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