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Newsletter
Vol 96 - August 2012
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 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.
Key to Label Sections:
BW - Boxed Warning C - Contraindications
W - Warnings P - Precautions
AR - Adverse Reactions PPI - Patient Package Insert
MG - Medication Guide PCI - Patient Counseling Information

  Sections Modified
Drug Name BW C W P AR PPI MG PCI
Avinza
(morphine sulfate) Extended-Release Capsules 
x x x x - - - -
Butrans
(buprenorphine) Transdermal System
x x x x - - - -
Dantrium
(dantrolene sodium) Oral Capsule
x - x x x - - -
Dolophine
(methadone hydrochloride) Tablets
x x x x - - - -
Duragesic
(Fentanyl Transdermal System)
x x x x - - - -
Embeda
(morphine sulfate and naltrexone hydrochloride) Extended-Release Capsules 
x x x x - - - -
Exalgo
(hydromorphone HCl) Extended-Release Tablets 
x x x x - - - -
Kadian
(morphine sulfate) Extended-Release Capsules
x x x x - - - -
Methadone hydrochloride Oral Solution and Concentrate
x x x x - - - -
MS Contin
(Morphine Sulfate Controlled-Release) Tablets
x x x x - - - -
Nucynta ER
(tapentadol) Extended-Release Oral Tablets
x x x x - - - -
Opana ER
(oxymorphone hydrochloride) Extended-Release Tablets
x x x x - - - -
Oxycontin
(oxycodone hydrochloride controlled-release) Tablets
x x x x - - - -
Truvada
(emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) Tablets
x x x x - - - -
AzaSite
(azithromycin ophthalmic solution)
- x - - - - - -
Biaxin Filmtabs
(clarithromycin tablets) Biaxin Granules (clarithromycin for oral suspension, USP)Biaxin XL Filmtabs (clarithromycin extended release tablets)
- x x x x - - -
Diovan
(valsartan) Tablets and Diovan HCT (valsartan/hydrochlorothiazide)
- x x x x - - -
Caduet
(amlodipine/atorvastatin) Tablets
- - x x x - - -
Eraxis
(anidulafungin) Powder for Injection
- - x x - - - -
Mirapex
(pramipexole dihydrochloride)
- - x x x - - -
Natrecor
(nesiritide) for Injection 
- - x x x - - -
Prograf
(tacrolimus) Capsules and Injection
- - x x x - - -
Sanctura
(trospium chloride)
- - x x x - - -
Strattera
(atomoxetine hydrochloride) capsule
- - x x - - - -
Zinecard
(dexrazoxane) for injection
- - x x - - - -
Mircette
(desogestrel/ethinyl estradiol and ethinyl estradiol) Tablets
- - - x - - - -
Qvar
(beclomethasone dipropionate HFA) Inhalation
- - - x x - - -
Somavert
(pegvisomant for injection)
- - - x x - - -
Sylatron
(peginterferon alfa-2b)
- - - x - - - -
Thyrogen
(thyrotropin alfa for injection)
- - - x x - - -
Trental
(pentoxifylline) Extended-Release Tablets
- - - x x - - -
Victrelis
(boceprevir) Capsules
- - - x - - - -
Faslodex
(fulvestrant) Injection
- - - - x - - -
Lumizyme
(alglucosidase alfa)
- - - - x - - -
Lupron Depot
(leuprolide acetate for depot suspension)
- - - - x - - -
Myozyme
(alglucosidase alfa)
- - - - x - - -
Ocufen
(flurbiprofen sodium ophthalmic solution, USP)
- - - - x - - -
Proleukin
(aldesleukin)
- - - - x - - -
VESIcare
(solifenacin succinate) Tablets
- - - - x - - -
Welchol
(colesevelam HCl) Tablets and Oral Suspension
- - - - x - - -
Zytiga
(abiraterone acetate) Tablets
- - - - x - - -
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.
FDA MedWatch Alerts
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