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Newsletter
Vol 75 - November 2010
Featured News
Confusing Labeling Found on Many Nonprescription Kids' Meds
November 2010
The admonishment to parents to carefully follow the directions on the labels of over-the-counter kids' medicines may be futile, new research suggests. Read more...
New Drug Approvals
The following drugs have recently been approved by the FDA.
Date of Approval: November 23, 2010
Treatment for: Hypogonadism -- Male
Axiron Drug Information | Press Release
Date of Approval: November 19, 2010
Treatment for: Cerebral Spasticity, Chronic Spasticity
Gablofen Drug Information | Press Release
Date of Approval: November 18, 2010
Treatment for: Osteolytic Bone Metastases of Solid Tumors
Xgeva Drug Information | Press Release
Date of Approval: November 15, 2010
Treatment for: Breast Cancer
Halaven Drug Information | Press Release
Date of Approval: November 10, 2010
Treatment for: Reduction of Excess Abdominal Fat in HIV-Infected Patients with Lipodystrophy
Egrifta Drug Information | Press Release
Date of Approval: November 5, 2010
Treatment for: Diabetes Mellitus Type II
Kombiglyze XR Drug Information | Press Release
Date of Approval: November 2, 2010
Treatment for: Fever, Pain
Ofirmev Drug Information | Press Release
Date of Approval: October 29, 2010
Treatment for: Pseudobulbar Affect
Nuedexta Drug Information | Press Release
Date of Approval: October 29, 2010
Treatment for: Pneumonia, Skin and Structure Infection
Teflaro 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 Formulation Approved: November 16, 2010
Now Approved: Nexterone Ready-to-Use Premixed Injection
Nexterone Drug Information | Press Release
New Indication Approved: November 4, 2010
Now Approved for: Chronic Musculoskeletal Pain
Cymbalta Drug Information | Press Release
Patient Population Altered: November 10, 2010
Now Approved for: ADHD in Adolescents
Vyvanse 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.
Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension
equivalent to 10 mg hydrocodone bitartrate and 8 mg chlorpheniramine maleate per 5 mL
Approved: October 1, 2010 - Tris Pharma, Inc.
Generic for: Tussionex Pennkinetic Extended-Release Oral Suspension
Zolpidem Tartrate Extended-Release Tablets
USP 6.25 mg
Approved: October 13, 2010 - Actavis South Atlantic LLC
Generic for: Ambien CR
Lansoprazole Delayed-Release Orally Disintegrating Tablets
15 mg and 30 mg
Approved: October 15, 2010 - Teva Pharmaceuticals USA
Generic for: Prevacid SoluTab Delayed-Release Orally Disintegrating Tablets
Propafenone Hydrochloride Extended-Release Capsules
225 mg, 325 mg and 425 mg
Approved: October 18, 2010 - Par Pharmaceutical, Inc.
Generic for: Rythmol SR Capsules
FDA Drug Safety Labeling Changes
This is a summary of the FDA drug labeling changes for October 2010. 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
Altace
(ramipril) capsules
x - x x - - - -
Letairis
(ambrisentan) tablets
x x x x x - - -
Invirase
(saquinavir mesylate) tablets
- x x x - - - -
Aldara
(imiquimod) cream
- - x x - - - -
Depo-Provera Contraceptive injection
(medroxyprogesterone acetate) injectable suspension
- - x x - - - -
Enablex
(darifenacin) extended-release tablets
- - x x x x - -
Fragmin
(dalteparin sodium) injection
- - x x - - - -
Gris-PEG
(griseofulvin ultramicrosized) tablets
- - x - x - - -
Motrin Junior Strength chewable tablets, 100 mg
- - x - - - - -
Lamictal
(lamotrigine) tablets, chewable dispersible tablets, Lamictal ODT (lamotrigine) orally disintegrating tablets, and Lamictal XR (lamotrigine) extended-release tablets
- - x x - - - -
Lasix
(furosemide) tablets
- - x x x - - -
Myfortic
(mycophenolic acid) delayed-release tablet
- - x x - - - -
Nexavar
(sorafenib tosylate) tablets
- - x x x - - -
Nuvigil
(armodafinil) tablets
- - x - - - - -
Precedex
(dexmedetomidine hydrochloride) injection
- - x x x - - -
Procardia XL
(nifedipine) extended release tablets
- - x x x - - -
Provigil
(modafinil) tablets
- - x - - - - -
Rebetol
(ribavirin) capsules and oral solution
- - x x - - - -
Rythmol SR
(propafenone hydrochloride) extended-release capsules
- - x x x - - -
Sprycel
(dasatinib) tablets
- - x x - - - -
Combivir
(lamivudine/zidovudine) tablets
- - - x - - - -
Cyanokit
(hydroxocobalamin) intravenous use
- - - x - - - -
Eligard
(leuprolide acetate) for injectable suspension
- - - x - - - -
Finacea
(azelaic acid) gel
- - - x - - - -
Paxil
(paroxetine HCl) tablets, oral solution and Paxil CR tablets
- - - x x - - -
Stalevo
(levodopa/carbidopa/entacapone) tablets
- - - x - - - -
Cancidas
(caspofungin acetate) for Injection
- - - - x - - -
Copegus
(ribavirin) tablets
- - - - x - - -
Lupron Depot and Lupron Depot 3 month
(leuprolide acetate) for depot suspension
- - - - x - - -
Proscar
(finasteride) tablets
- - - - x x - -
Viread
(tenofovir disoproxil fumarate) tablets
- - - - x - - -
Accolate
(zafirlukast) tablets
- - - - - x - -
Pristiq
(desvenlafaxine) extended-release tablets
- - - - - - - -
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 Rates Lower With Less Hormone Therapy: Study
November 30, 2010
Reduced use of hormone replacement therapy (HRT) is linked to declines in rates of invasive breast cancer and ductal carcinoma in situ, the most common form of noninvasive breast cancer, a new study reports.
Prescriptions for Stimulants, Painkillers Soaring Among Youth
November 30, 2010
The number of prescriptions for controlled medications such as opioids and stimulants has nearly doubled in adolescents and young adults since 1994.
Celebrex Shows Potential in Preventing Some Skin Cancers: Study
November 29, 2010
The prescription painkiller Celebrex might help prevent non-melanoma skin cancers, a small study suggests.
Smarten Up About Antibiotics, CDC Urges
November 18, 2010
Knowing when to take antibiotics - and when not to - can help fight the rise of deadly "superbugs," say experts at the United States Centers for Disease Control and Prevention.
Warfarin Patients Often Unaware of Risks from Herbs, Supplement Use
November 15, 2010
Warfarin patients who use herbal and dietary supplements are often unaware that combining them with the blood thinner may make it ineffective and even dangerous, new research suggests.
Severe Acne May Up Suicide Risk: Study
November 11, 2010
Severe acne may significantly increase suicide risk, and patients taking isotretinoin (Accutane) for the skin condition should be monitored for at least a year after treatment ends, Swedish researchers report.
Painkillers in Pregnancy May Harm Son's Fertility, Study Suggests
November 11, 2010
Pregnant women who use mild painkillers may boost the risk that their male children will grow up to be infertile, a new European study suggests.
Long-Term Statin Use Won't Raise Cancer Risk: Study
November 10, 2010
Long term use of cholesterol-lowering drugs called statins does not increase the risk of cancer and may even decrease users' risks for lymphoma, melanoma and endometrial tumors, a new study finds.
Few Young Women Getting Cervical Cancer Vaccine
November 9, 2010
Few teenage girls and young women are getting the human papillomavirus vaccine (HPV), and many of those who start the regimen fail to take all three doses, new research reveals.
New Malaria Drug Proves Effective in Study of African Children
November 6, 2010
The death rate among children with severe malaria was nearly one-fourth lower when they received a new drug called artesunate than when they got the standard treatment of quinine, a new study shows.
Fish Oil Supplements May Not Slow Alzheimer's
November 2, 2010
One of the main components of fish oil doesn't help slow the development of symptoms in patients with early Alzheimer's, although experts aren't ruling out the possibility that supplementation given earlier might help prevent the disease.
FDA MedWatch Alerts
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