You are receiving this email from Drugs.com because you are subscribed to our newsletter list. Not interested anymore? Unsubscribe Instantly

Drugs.com Logo
Newsletter
Vol 80 - April 2011
Featured News
Novel Hepatitis C Drug Holds Promise: FDA
April 2011
An experimental new drug that may treat hepatitis C more effectively than earlier medications will be reviewed Thursday by a panel of experts for the U.S. Read more...
New Drug Approvals
The following drugs have recently been approved by the FDA.
Date of Approval: April 23, 2011
Treatment for: Osteoarthritis, Rheumatoid Arthritis, NSAID-Induced Ulcer Prophylaxis
Duexis Drug Information | Press Release
Date of Approval: April 11, 2011
Treatment for: Malignant Melanoma
Sylatron Drug Information | Press Release
Date of Approval: April 6, 2011
Treatment for: Restless Legs Syndrome
Horizant Drug Information | Press Release
Date of Approval: April 6, 2011
Treatment for: Thyroid Cancer
vandetanib 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: April 25, 2011
Now Approved for: Conversion to Monotherapy for Treatment of Partial Seizures
Lamictal XR Drug Information | Press Release
New Indication Approved: April 15, 2011
Now Approved for: Systemic Juvenile Idiopathic Arthritis
Actemra Drug Information | Press Release
New Indication Approved: April 19, 2011
Now Approved for: Wegener's Granulomatosis and Microscopic Polyangiitis
Rituxan Drug Information | Press Release
Patient Population Altered: April 6, 2011
Now Approved for: Schizophrenia in Adolescents 12 to 17 years
Invega Drug Information | Press Release
Patient Population Altered: April 22, 2011
Now Approved for: Prevention of Meningococcal Disease in Infants (9-23 months of age)
Menactra 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.
Norgestimate and Ethinyl Estradiol Tablets
USP, 0.18 mg/0.025 mg, 0.215 mg/0.025 mg, 0.25 mg/0.025 mg (28-Day Regimen)
Approved: March 9, 2011 - Watson Laboratories, Inc.
Generic for: Ortho Tri-Cyclen Lo Tablets
Epinastine Hydrochloride Ophthalmic Solution
0.05%
Approved: March 14, 2011 - Cypress Pharmaceutical, Inc.
Generic for: Elestat Ophthalmic Solution
FDA Drug Safety Labeling Changes
This is a summary of the FDA drug labeling changes for February 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
Avandaryl
(rosiglitazone maleate/glimepiride) Tablets
x - x x x - - -
Proquin XR
(ciprofloxacin) Extended-Release Tablets
x - x x x - - -
Flector Patch
(diclofenac epolamine topical patch)
- x - - - - - -
Increlex
(mecasermin [rDNA origin] injection
- x x x x - - -
Toviaz
(fesoterodine fumarate) extended release tablets
- x x x - - - -
Heparin Sodium Injection
- - x - - - - -
Humatrope
(somatropin [rDNA origin]) for injection
- - x x x - - -
Kaletra
(lopinavir/ritonavir) Tablets and Oral Solution
- - x x - - - -
Multaq
(dronedarone hydrochloride) Tablets
- - x x x - - -
Prilosec OTC
(omeprazole magnesium) delayed-release tablets
- - x - - - - -
Promacta
(eltrombopag) Tablets
- - x x - - - -
Remicade
(Infliximab)
- - x x x - - -
Tekturna
(aliskiren)and Tekturna HCT(aliskiren/hydrochlorothiazide) Tablets
- - x x x - - -
Valturna
(aliskiren/valsartan) Tablets
- - x x x - - -
Zebeta
(bisoprolol fumarate) Tablets
- - x - - - - -
Adalat CC
(nifedipine)  Extended Release Tablets
- - - x x - - -
Betapace
(sotalol hydrochloride) and Betapace AF (sotalol hydrochloride) Tablets
- - - x - - - -
Cataflam
(diclofenac potassium immediate-release tablets)
- - - x x - - -
NebuPent
(pentamidine isethionate)
- - - x - - - -
Talwin Nx
(pentazocine hydrochloride and naloxone Hydrochloride) Tablets
- - - x - - - -
Tazorac
(tazarotene) Gel
- - - x x - - -
Viracept
(nelfinavir mesylate) Oral Powder and Tablets
- - - x - x - -
Voltaren
(diclofenac sodium enteric-coated tablets) and Voltaren-XR (diclofenac sodium extended-release) tablets
- - - x x - - -
Adenoscan
(adenosine) Injection
- - - - x - - -
Isentress
(raltegravir potassium) Tablets
- - - - x - - -
Micronase
(glyburide) tablets
- - - - x - - -
Pegasys
(ß (peginterferon alfa-2a)
- - - - x - - -
Simcor
(niacin extended release/simvastatin) Tablets
- - - - x - - -
Vantas
(histrelin acetate) subcutaneous implant
- - - - x - - -
Zometa
(zoledronic acid for injection)
- - - - x - - -
Brovana
(arformoterol) Inhalation Solution
- - - - - - - -
Perforomist
(formoterol fumarate) Inhalation Solution
- - - - - - - -
Plavix
(clopidogrel bisulfate) Tablets
- - - - - - - -
Symbicort
(budesonide and formoterol) Inhalation Aerosol
- - - - - - - -
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
Many Kids With Epilepsy Don't Take Meds as Prescribed: Study
April 26, 2011
Nearly three of every five children diagnosed with epilepsy do not take their antiseizure medicine as prescribed over the first six months of treatment, a new study shows.
Antidepressants Work Overall, But Some Symptoms May Persist
April 26, 2011
Antidepressants may not improve all symptoms of depression, according to a new study.
Heart-Healthy Omega-3s Not Healthy for Prostate: Study
April 25, 2011
High levels of heart-healthy omega-3 fatty acids in the blood may be associated with an increased risk for developing aggressive prostate cancer, while elevated levels of unhealthy trans-fatty acids may lower the risk, a new study suggests.
Common Painkillers May Blunt Antidepressants
April 25, 2011
Common over-the-counter painkillers such as ibuprofen, aspirin and naproxen may reduce the effectiveness of antidepressants called selective serotonin reuptake inhibitors, or SSRIs, according to a mouse and human study from The Rockefeller University in New York City.
Experts Offer New Guidance for Blood Pressure Control in Elderly
April 25, 2011
Elderly Americans are at high risk for high blood pressure and related health problems and death, but lifestyle changes and proper use of medicines can reduce these risks, says a clinical guidance statement released Monday by the American Heart Association and the American College of Cardiology.
Scientists Discover How Peppermint Soothes Gastric Pain
April 22, 2011
New research offers insight into how peppermint helps relieve the symptoms of irritable bowel syndrome.
Newer 'Pill' Linked to Higher Risk of Blood Clots
April 21, 2011
Newer forms of birth control pills may carry a higher risk of serious blood clots than earlier oral contraceptives.
Women Taking Calcium Supplements May Risk Heart Health, Researchers Say
April 19, 2011
More evidence is emerging that women who take calcium supplements to prevent bone deterioration may, in fact, be risking their heart health.
Children With HIV at Higher Risk of Drug Resistance
April 19, 2011
About 1 in 8 children infected with HIV experiences triple-class virological failure - meaning the virus becomes resistant to multiple drugs - within five years of starting antiretroviral treatment, a European study shows.
Most Parents Vaccinate Kids, Trust Docs' Advice on Shots
April 19, 2011
About 93 percent of parents said their children either had or were going to get all of the recommended vaccinations, and more than three-fourths said they trusted their doctor's advice on immunizations, two new surveys find.
Alcohol-Energy Drink Combo Riskier Than Booze Alone, Study Says
April 15, 2011
Combining the caffeine jolt of energy drinks with the intoxicating effects of alcohol is riskier than drinking alcohol alone, a new study suggests.
New Treatment for Urinary Tract Infections Called Promising
April 15, 2011
Many women suffer from chronic urinary tract infections, but now a new treatment using a probiotic may provide lasting relief for some, a preliminary trial indicates.
Estrogen's Role in Breast Cancer Can Fluctuate
April 15, 2011
Is estrogen breast cancer's friend or foe? A recent study in the Journal of the American Medical Association, which analyzed data from the massive Women's Health Initiative, suggested the latter when it found a reduced risk of breast cancer in women who had been on short-term estrogen therapy.
Use of Dietary Supplements Keeps Climbing: CDC
April 13, 2011
More than half of American adults take dietary supplements, such as multivitamins and calcium, and their use jumped dramatically over a recent 20-year period, according to a new government report.
Fish Oil Promising Against Postpartum Depression in Small Trial
April 12, 2011
Consuming omega-3 fatty acids in fish oil capsules during pregnancy may reduce a woman's risk of postpartum depression, according to a new study.
Extended HPV Vaccine Schedule Seems Effective
April 12, 2011
Giving doses of human papillomavirus (HPV) vaccine over a longer-than-normal period of time may prove an effective way to make the vaccine available to more females in poorer nations, a new study suggests.
Drug Memantine Ineffective for Mild Alzheimer's, Study Finds
April 11, 2011
A drug commonly prescribed for Alzheimer's disease, memantine (Namenda), appears to be ineffective in treating the mild stage of the disease, a new study finds.
Acne Antibiotics Not Linked to Drug Resistance
April 11, 2011
Long-term use of antibiotics to treat acne doesn't seem to spur bacteria into becoming resistant to the medications, a new study finds.
Brain Tumor Vaccine Shows Promise in Early Trials
April 11, 2011
A vaccine that jumpstarts the immune system is showing promise in keeping a deadly type of cancerous brain tumor at bay.
Certain Diabetes Drugs Better for Heart Health, Study Finds
April 7, 2011
The commonly used oral diabetes drug metformin not only helps stabilize blood sugar levels, it also may offer protection against heart disease, researchers say.
Antibiotic-Resistant Bacteria in India Could Spread, Experts Say
April 7, 2011
A gene that helps bacteria resist nearly all antibiotics is present in bacteria in public water supplies in New Delhi, India, researchers have found.
Two Different Heart Drugs May Work Equally Well for High-Risk Patients
April 5, 2011
People with high blood pressure and impaired glucose tolerance seem to fare equally well when given two separate types of heart drugs, new research suggests.
Monthly Aspirin Use Linked to Lower Pancreatic Cancer Risk
April 4, 2011
Taking aspirin even once per month, whether low-dose or full strength, appears to be associated with a marked drop in the risk of developing pancreatic cancer, new research reveals.
FDA MedWatch Alerts
Tools & Helpful Links
Community Discussion Forums
We welcome you to share your experiences.
Medical Encyclopedia
Use this feature to find information on diseases, symptoms, injuries, medical tests and surgical procedures.
Browse by Medical Condition
Use this feature to find drugs or medication related to a condition or therapeutic group.
Pill Identifier
The Pill Identifier enables a search for unidentified pills by imprint code or shape/color.
Drug Interactions Checker
Increasingly popular as more healthcare professionals and consumers make the effort to seek detailed information on drug-drug and drug-food interactions.
New Drugs
All the latest information on FDA Approvals and recent additions to the database.
News & Articles
Roundup of recent drug-related news and press releases. also latest news from FDA Medwatch service including timely publication of recalls, withdrawals, warnings, and label/packaging changes.
About This Newsletter
Drugs.com is not affiliated with any pharmaceutical company. We are dedicated to providing consumers and health professionals with objective information about prescription-medication discoveries and side effects.
This information is not intended to be medical advice. You should contact your physician before making any changes to your health care. Drugs.com is not responsible for content provided by third-party web sites.
About Your Subscription
We sent this e-mail to %PERS_EMAIL% at your request.
Your Feedback
We always appreciate feedback so if you wish to give us your comments/ praise/ rebuke please Contact Us.
Thanks so much for your continued support!
The Editorial Team
Drugs.com
Your Privacy - Any personal information you provide to us will only be used to notify you of offers, information and activities.
We'll hold the information about you securely and will not disclose it except for this purpose, or when required by law.
Copyright © 2011 Drugs.com. All Rights Reserved.

Click Here to Unsubscribe Instantly.