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Newsletter
Vol 84 - August 2011
Featured News
Monthly Roundup - August 2011
August 2011
Two Targeted Therapies Approved: Xalkori and Zelboraf for Aggressive Cancers Two advanced cancer treatments with accompanying diagnostic genetic tests have been approved this month. Read more...
New Drug Approvals
The following drugs have recently been approved by the FDA.
Date of Approval: August 26, 2011
Treatment for: Non-Small Cell Lung Cancer
Xalkori Drug Information | Press Release
Date of Approval: August 25, 2011
Treatment for: Angioedema
Firazyr Drug Information | Press Release
Date of Approval: August 19, 2011
Treatment for: Lymphoma, Hodgkin's Disease
Adcetris Drug Information | Press Release
Date of Approval: August 17, 2011
Treatment for: Melanoma - Metastatic
Zelboraf 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: August 25, 2011
Now Approved: Nucynta ER
Nucynta Drug Information | Press Release
New Indication Approved: August 24, 2011
Now Approved for: Urinary Incontinence
Botox 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.
Fondaparinux Sodium Injection
2.5 mg/0.5 mL, 5 mg/0.4 mL, 7.5 mg/0.6 mL and 10 mg/0.8 mL
Approved: July 11, 2011 - Dr. Reddy's Laboratories Limited
Generic for: Arixtra
Alfuzosin Hydrochloride Extended-Release Tablets
10 mg
Approved: July 18, 2011 - Apotex Inc.; Mylan Pharmaceuticals, Inc.; Torrent Pharmaceuticals; Teva Pharmaceuticals USA; Sun Pharmaceutical Industries Limited
Generic for: Uroxatral
Metronidazole Topical Gel
1%
Approved: July 22, 2011 - Tolmar, Inc.
Generic for: Metrogel 1%
Phentermine Resin Complex Extended-Release Capsules
15 mg (base) and 30 mg (base)
Approved: July 28, 2011 - Lannett Company, Inc.
Generic for: Ionamin
FDA Drug Safety Labeling Changes
This is a summary of the FDA drug labeling changes for July 2011. 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
Epogen/Procrit
(epoetin alfa) and Aranesp (darbepoetin alfa)
x - x x - - - -
Dostinex
(cabergoline) Tablets
- x x - - - - -
Nitrostat
(nitroglycerin, USP) Sublingual Tablets
- x - x - x - -
Paxil
(paroxetine HCl) tablets, oral solution and Paxil CR tablets
- x - x - - - -
Ranexa
(Ranolazine) Extended-Release Tablets
- x x x - - - -
Rotavirus Vaccine, Live, Oral, Pentavalent
(RotaTeq)
- x - - - x - -
Arava
(leflunomide) Tablets
- - x x - - - -
Bentyl
(dicyclomine hydrochloride, USP) Capsules/Tablets, Oral Syrup, Injection
- - x x - - - -
Chantix
(varenicline) Tablets
- - x x x - - -
Flomax
(tamsulosin hydrochloride) Capsules
- - x x - - - -
Gilenya
(fingolimod) capsules 0.5 mg
- - x x - - - -
Kenalog-10
(triamcinolone acetonide) Injection Kenalog-40 (triamcinolone acetonide) Injection
- - x - x - - -
Micardis
(telmisartan) Tablets
- - - x - - - -
Prograf
(tacrolimus) Capsules, Injection
- - x x x - - -
Seroquel
(quetiapine fumarate) Tablets Seroquel (quetiapine fumarate) XR
- - x x x - - -
Tev-Tropin
(somatropin [rDNA origin]) for injection
- - x x x - - -
Truvada
(emtricitabine/tenofovir disoproxil fumarate) tablets
- - x x - - - -
Zegerid OTC
(omeprazole 20mg and sodium bicarbonate 1100 mg) capsules
- - x - - - - -
Cordran
(flurandrenolide, USP) Lotion
- - - x x - - -
Creon
(pancrelipase) delayed-release capsules
- - - x x - - -
 
- - - x - - - -
Mobic
(meloxicam) Tablets, Oral Suspension
- - - x - - - -
Spiriva HandiHaler
(tiotropium bromide inhalation powder)
- - - x - - - -
Wellbutrin XL
(bupropion hydrochloride) Extended-Release Tablets Aplenzin (bupropion hydrobromide) Extended-Release Tablets
- - - x - - - -
Wellbutrin
(bupropion hydrochloride) Wellbutrin SR (bupropion hydrochloride) Sustained-Release Tablets 
- - - x - - - -
Coreg
(carvedilol) Tablets Coreg CR (carvedilol phosphate) Extended Release Capsules
- - - - x - - -
Flovent HFA
(fluticasone propionate) Inhalation Aerosol
- - - - x - - -
Ortho Evra
(norelgestromin and ethinyl estradiol) transdermal system
- - - - x x - -
Actiq
(fentanyl citrate) oral transmucosal lozenge
- - - - - - - -
Colcrys
(colchicine) Tablets
- - - - - - - -
Fentora
(fentanyl buccal tablets)
- - - - - - - -
Tikosyn
(dofetilide) Capsules
- - - - - - - -
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
HPV Vaccination Rates Low Among Teen Girls, CDC Reports
August 25, 2011
Teen vaccination rates for human papillomavirus (HPV) are lagging behind rates for two other important vaccines in the United States, federal researchers say.
U.S.-Mandated Report Finds Vaccines Safe for Kids
August 25, 2011
An exhaustive new report from experts at the Institute of Medicine finds that children's vaccines are typically safe, with bad reactions occurring only rarely and then not causing any lasting medical problems.
Mainstay Meds Often Cut Off Accidentally After Hospital Stay
August 23, 2011
Many patients who are hospitalized fail to receive their regular medications for chronic conditions during their stay and often fail to restart them when they're discharged, researchers say.
Excessive Heat Can Harm Medications, Expert Says
August 20, 2011
Medications can be harmed by high temperatures, say pharmacists.
Don't Skip This Year's Flu Shot: CDC
August 18, 2011
The 2011-12 flu vaccine protects against seasonal flu and H1N1, just like last year's, but that doesn't mean it's OK to skip your yearly flu shot, researchers from the Centers for Disease Control and Prevention warn.
Kids Benefit From Flu Vaccine via Shot or Spray, Study Finds
August 18, 2011
Children younger than 3 years old receive roughly the same amount of protection from the flu vaccine regardless of which method (injection, nasal spray, or one of each) is used to give the two recommended doses to them, according to a new federal study.
New Uses Found for Old Drugs
August 17, 2011
Many drugs already approved to combat certain illnesses may also be helpful in treating a slew of other seemingly unrelated health problems, a new study indicates.
Antipsychotics Best for Controlling Mania: Study
August 16, 2011
The manic episodes experienced by those with bipolar disorder are better controlled by antipsychotic drugs than mood stabilizers, a new, large study suggests.
U.S. Women Using Dangerous Weight-Loss Pill 2 Years After Recall
August 16, 2011
Many women in the United States continue to use a Chinese weight-loss supplement that's been recalled due to dangerous ingredients, a new study indicates.
Patients Taking Antipsychotics Urged to Get Routine Physicals
August 12, 2011
Patients who take antipsychotic medications aren't being adequately monitored for dangerous health complications, researchers have found.
Depression Linked to Increased Risk of Stroke in Women
August 12, 2011
Depressed women may face an increased risk of stroke, according to new research reported in Stroke: Journal of the American Heart Association.
Americans' Use of Antidepressants On the Rise: Study
August 4, 2011
Americans are popping more antidepressants than ever before to deal with everyday stress, and non-psychiatrists are increasingly willing to prescribe the drugs to patients with no mental health diagnosis, a new study finds.
Popular Antidepressants Not Always Best Choice for Seniors
August 2, 2011
New research suggests that hugely popular antidepressants such as Prozac and Effexor might not always be the best choice for seniors, since they seem to have more side effects than older antidepressants do.
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