You received this email because you are subscribed to updates from Drugs.com. Change your notification settings or unsubscribe here.

Drugs.com Logo
Newsletter
Vol 94 - June 2012
Featured News
Monthly News Round Up - June 2012
June 2012
Belviq (lorcaserin) Approved For Obesity Treatment In a long awaited decision, the FDA has approved the weight-loss drug Belviq (lorcaserin). Read more...
New Drug Approvals
The following drugs have recently been approved by the FDA.
Date of Approval: June 28, 2012
Treatment for: Overactive Bladder
Myrbetriq Drug Information | Press Release
Date of Approval: June 27, 2012
Treatment for: Obesity
Belviq Drug Information | Press Release
Date of Approval: June 14, 2012
Treatment for: Haemophilus influenzae Prophylaxis, Meningococcal Meningitis Prophylaxis
MenHibrix Drug Information | Press Release
Date of Approval: June 8, 2012
Treatment for: Breast Cancer
Perjeta 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 Indication Approved: June 6, 2012
Now Approved for: Postherpetic Neuralgia
Horizant Drug Information | Press Release
New Indication Approved: June 25, 2012
Now Approved for: Multifocal Motor Neuropathy
Gammagard Liquid Drug Information | Press Release
New Indication Approved: June 20, 2012
Now Approved for: Neuropathic Pain Associated with Spinal Cord Injury
Lyrica 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.
Armodafinil Tablets
50 mg, 150 mg and 250 mg
Approved: June 1, 2012 - Mylan Pharmaceuticals, Inc.
Generic for: Nuvigil
Adapalene Gel
0.3%
Approved: June 14, 2012 - Tolmar, Inc.
Generic for: Differin Gel 0.3%
Abacavir Sulfate Tablets
300 mg (base)
Approved: June 18, 2012 - Mylan Pharmaceuticals Inc.
Generic for: Ziagen
Olanzapine and Fluoxetine Hydrochloride Capsules
25 mg (base)/6 mg (base), 25 mg (base)/12 mg (base), 50 mg (base)/6 mg (base) and 50 mg (base)/12 mg (base)
Approved: June 19, 2012 - Teva Pharmaceuticals USA Inc.
Generic for: Symbyax
Metformin Hydrochloride and Pioglitazone Hydrochloride Tablets
500 mg/15 mg (base) and 850 mg/15 mg (base)
Approved: June 26, 2012 - Mylan Pharmaceuticals, Inc.
Generic for: Actoplus Met
Linezolid Injection
200 mg/100 mL
Approved: June 27, 2012 - Teva Pharmaceuticals USA Inc.
Generic for: Zyvox Injection
Cidofovir Injection
75 mg (base)/mL
Approved: June 27, 2012 - Mylan Pharmaceuticals, Inc.
Generic for: Vistide
FDA Drug Safety Labeling Changes
This is a summary of the FDA drug labeling changes for May 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
Lotensin
(benazepril)
x - x x x - - -
Divigel
(estradiol gel)
- x x x - - - -
Focalin
(dexmethylphenidate hydrochloride)
- x - - x - - -
Focalin XR
(dexmethylphenidate hydrochloride) 
- x - - x - - -
Gilenya
(Fingolimod)
- x x x x - - -
2% Chlorhexidine Gluconate
(CHG) Cloth
- - x - - - - -
Aciphex
(rabeprazole sodium) Delayed-Release Tablets
- - x x - - - -
Actoplus Met
(pioglitazone hydrochloride plus metformin hydrochloride) Tablets
- - x x x - - -
Aredia
(pamidronate disodium) for Injection
- - x x x - - -
Avagard Surgical and Healthcare Personnel Hand Antiseptic
(chlorhexidine gluconate 1% solution and ethyl alcohol 61% w/w) Lotion
- - x - - - - -
Biaxin Granules
(clarithromycin for oral suspension, USP)
- - x x - - - -
Biaxin Filmtabs
(clarithromycin tablets, USP)
- - x x - - - -
Biaxin XL Filmtabs
(clarithromycin extended release tablets) 
- - x x - - - -
Catapres
(clonidine hydrochloride) Tablets
- - x x - - - -
Catapres-TTS
(clonidine) Transdermal Therapeutic System
- - x x - - - -
Chlorascrub Swabsticks
- - x - - - - -
Dexilant
(dexlansoprazole) delayed-release capsules
- - x x - - - -
Folotyn
(pralatrexate injection)
- - x x x - - -
Hibiclens
(4% w/v chlorhexidine gluconate) solution
- - x - - - - -
Hibistat
(0.5% chlorhexidine gluconate solution and 70% isopropyl alcohol w/w)
- - x - - - - -
Omeprazole/Sodium Bicarbonate/Magnesium Hydroxide Tablets
- - x x - - - -
Prevacid
(lansoprazole) Delayed-Release CapsulesPrevacid (lansoprazole) Delayed-Release Orally Disintegrating Tablets
- - x x - - - -
Protonix
(pantoprazole sodium) For Injection
- - x x - - - -
Protonix
(pantoprazole sodium) For Delayed-Release Oral SuspensionProtonix (pantoprazole sodium) Delayed-Release Tablets
- - x x - - - -
Scrub-Stat 2% and Scrub-Stat 4%
(chlorhexidine gluconate 2% and 4%) Solutions
- - x - - - - -
Ultravist
(brand of iopromide) Injection
- - x x x - - -
Ultravist
(brand of iopromide) Injection Pharmacy Bulk Pack
- - x x x - - -
Zarontin
(ethosuximide) Capsules
- - x x x - - -
Cubicin
(daptomycin for injection) Intravenous
- - - x - - - -
Effexor
(venlafaxine HCl) TabletsEffexor XR (venlafaxine HCl) Extended-Release Capsules
- - - x - - - -
Ella
(ulipristal acetate)
- - - x - - - -
Levemir
(insulin detemir [rDNA origin]), Injection
- - - x x - - -
Prolia
(denosumab) 
- - - x - - - -
Stelara
(ustekinumab) Injection
- - - x x - - -
Tradjenta
(linagliptin) Tablets
- - - x x - - -
Venlafaxine HCl Extended-release Tablets
- - - x - - - -
Amevive
(alefacept)
- - - - x - - -
Avastin
(bevacizumab)
- - - - x - - -
DuoNeb
(albuterol sulfate and ipratropium bromide) Inhalation Solution
- - - - x - - -
Humira
(adalimumab)
- - - - x - - -
Neupogen
(filgrastim)
- - - - x x - -
Zestril
(lisinopril) tablets
- - - - x - - -
Zestoretic
(lisinopril/hydrochlorothiazide) tablets
- - - - x - - -
Dysport
(abobotulinumtoxinA)
- - - - - - - -
Revlimid
(lenalidomide) 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
Metformin Outperforms Common Class of Diabetes Drugs in Study
June 24, 2012
Three widely used diabetes drugs are associated with a greater risk of death when compared to a popular drug from a different class, metformin, according to a new study.
Effects of High Blood Pressure Drug May Mimic Celiac Disease
June 22, 2012
A new report suggests that the common blood pressure drug olmesartan (Benicar) can cause symptoms that mimic celiac disease, leading to misdiagnosis and unnecessary treatment.
Genes May Influence Reactions to Painkillers
June 20, 2012
Genetics play a major role in a person's risk for addiction or unpleasant side effects when taking opioid painkillers, new research suggests.
New Therapies Show Some Promise Against Pancreatic Cancer
June 19, 2012
Giving four weeks of a targeted drug before starting chemotherapy improved response rates in a small group of patients with advanced pancreatic cancer, University of Michigan researchers report.
Arthritis Treatment Linked to Liver Problems in Study
June 18, 2012
A "medical food" called Limbrel, which doctors prescribe to treat osteoarthritis of the knee, was linked to several cases of liver disease in a small study, but the effects so far seem to be rare and easily reversible.
Birth Control That Uses Combined Hormones Raises Heart Risk: Study
June 13, 2012
Sweeping new research comparing various forms of hormonal contraception - including birth control pills, vaginal rings and skin patches - suggests that the risk for heart attacks and strokes is twice as high among users of combined estrogen-progestin versions.
Older Women Should Not Take Calcium, Vitamin D: Task Force
June 12, 2012
A leading United States government advisory panel has proposed that postmenopausal women not take low-dose calcium and vitamin D supplements daily to ward off bone fractures.
Statins May Leave Patients With Less Energy: Study
June 11, 2012
Statins - the popular class of cholesterol-lowering drugs - significantly increase the risk of experiencing a drop in energy or becoming unduly tired when exercising, according to new research.
Diabetes Drugs Avandia, Actos Linked to Vision Woes
June 11, 2012
British researchers report that thiazolidinediones, diabetes medications that are used to help control blood sugar levels, may cause eye problems in those who take them.
New Medicine Might Fight Drug-Resistant TB, Study Says
June 6, 2012
More than four decades after the last introduction of fresh treatments for tuberculosis, a new medication for multidrug-resistant strains of the global scourge has shown promise in a multinational trial.
Antibiotic-Resistant Gonorrhea Spreading: WHO
June 6, 2012
Gonorrhea, the second most common sexually transmitted disease, is rapidly growing resistant to the last class of antibiotics that can effectively treat the infection, the World Health Organization warned Wednesday.
Daily Low-Dose Aspirin Risks Seem to Outweigh Gains for Many: Study
June 5, 2012
Unless you're at high risk for cardiovascular disease, you probably shouldn't take a low-dose aspirin every day, a new study suggests.
Ginseng Capsules Seem to Ease Cancer-Related Fatigue
June 4, 2012
The herb ginseng appeared to significantly reduce cancer-related fatigue compared to an inactive placebo, although it took several weeks for the herb's effects to take effect in the patients, a new study reports.
New 'Personalized' Drugs Show Promise Against Melanoma, Lung Cancer
June 4, 2012
There's more encouraging news from the brave new world of "personalized" cancer care, with three drugs showing promise against some of the most common cancers.
Antidepressant Cymbalta Might Ease Chemo-Linked Pain
June 4, 2012
Cancer patients on certain chemotherapies often experience a painful tingling in their extremities called peripheral neuropathy, and a new study suggests the antidepressant Cymbalta may be the first treatment to work against the condition.
Many Americans Taking Too Much Acetaminophen
June 1, 2012
Many U.S. adults are at risk for overdosing on over-the-counter pain relievers containing acetaminophen, according to a new study.
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.
Drugs.com Daily 300x250
powered byad choices
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 websites.
About Your Subscription
You received this email because you are subscribed to updates from Drugs.com. Change your notification settings or unsubscribe here.
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 © 2012 Drugs.com. All Rights Reserved.

You received this email because you are subscribed to updates from Drugs.com. Change your notification settings or unsubscribe here.