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Newsletter
Vol 95 - July 2012
Featured News
Monthly News Round Up - July 2012
July 2012
Vascepa Approved for Treatment of Severely High Triglyceride Levels The U.S. Read more...
New Drug Approvals
The following drugs have recently been approved by the FDA.
Date of Approval: July 26, 2012
Treatment for: Rheumatoid Arthritis, Polymyalgia Rheumatica, Psoriatic Arthritis, Ankylosing Spondylitis, Asthma, Chronic Obstructive Pulmonary Disease
Rayos Drug Information | Press Release
Date of Approval: July 26, 2012
Treatment for: Hypertriglyceridemia
Vascepa Drug Information | Press Release
Date of Approval: July 23, 2012
Treatment for: Chronic Obstructive Pulmonary Disease
Tudorza Drug Information | Press Release
Date of Approval: July 20, 2012
Treatment for: Multiple Myeloma
Kyprolis 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: July 20, 2012
Now Approved for: Advanced Breast Cancer
Afinitor Drug Information | Press Release
New Indication Approved: July 16, 2012
Now Approved for: Reducing the Risk of Sexually Acquired HIV Infection
Truvada 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.
Pregabalin Capsules
25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg
Approved: July 3, 2012 - Lupin Pharmaceuticals, Inc., Watson Pharmaceuticals, Inc., Teva Pharmaceuticals USA, Inc.
Generic for: Lyrica
Diclofenac Sodium and Misoprostol Delayed Release Tablets
50 mg/0.2 mg and 75 mg/0.2 mg
Approved: July 9, 2012 - Watson Pharmaceuticals, Inc.
Generic for: Arthrotec
Levonorgestrel Tablets (Next Choice One Dose)
1.5 mg
Approved: July 12, 2012 - Watson Pharmaceuticals, Inc.
Generic for: Plan B One-Step
Modafinil Tablets
100 mg and 200 mg
Approved: July 16, 2012 - Mylan Pharmaceuticals, Inc.
Generic for: Provigil
Entacapone Tablets
200 mg
Approved: July 16, 2012 - Sun Pharma Global
Generic for: Comtan
Fexofenadine Hydrochloride Oral Suspension
30 mg/5 mL
Approved: July 25, 2012 - Actavis Mid Atlantic
Generic for: Allegra Oral Suspension
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
Two New Weight-Loss Drugs Won't Reverse U.S. Obesity Crisis
July 19, 2012
The U.S. Food and Drug Administration's approval of two new weight-loss drugs within the past month - the first such medications in 13 years - won't be a panacea for America's obesity epidemic, health professionals say.
Top 100 Drug Sales Data Released - Plavix Leads the Way
July 18, 2012
Drugs.com Stats Center Lists the Top 100 Drugs Q1 2012 in the United States.
Guidelines Issued for New Blood Thinner Brilinta
July 16, 2012
The new blood-thinning drug Brilinta should be considered along with older drugs to treat patients with unstable angina, according to updated guidelines.
Aging Boomers' Mental Health Woes Will Swamp Health System: Report
July 10, 2012
The United States faces an unprecedented number of aging baby boomers with mental health or substance use issues, a number so great it could overwhelm the existing health care system, a new report warned Tuesday.
Teach Prescribers About Dangers of Long-Acting Pain Meds: FDA
July 9, 2012
As part of its efforts to curb the abuse of narcotic painkillers, the FDA is requiring drug makers to educate doctors about the risks of long-acting and extended-release forms of the drugs.
New Test Helps Evaluate Cancer Drug's Merit
July 9, 2012
A new genetic test to help doctors determine if the drug Erbitux would be an effective treatment for certain colorectal cancer patients has been approved by the Food and Drug Administration.
More Proof Cranberry Juice Thwarts Infection
July 9, 2012
Cranberry juice and cranberry supplements really do help prevent urinary tract infections, a new study confirms.
Medical Groups Agree on Use of Hormone-Replacement Therapy
July 9, 2012
A coalition of leading medical groups has concluded that hormone-replacement therapy can be useful and safe for many women suffering from the symptoms of menopause.
HPV Vaccine Reducing Infections, Even Among Unvaccinated: Study
July 9, 2012
Even among unvaccinated girls and young women, the human papillomavirus vaccine is reducing infections of certain strains of the virus known to cause genital warts and cervical cancer, new research finds.
Methadone for Pain Relief Leading Cause of Fatal Overdoses: CDC
July 3, 2012
Although methadone accounts for only 2 percent of the painkiller prescriptions in the United States, it is tied to more than 30 percent of painkiller overdose deaths, according to a government report released Tuesday.
Half of Heart Patients Make Mistakes With Their Meds: Study
July 3, 2012
Half of patients hospitalized for a heart attack or heart failure will make a mistake with their medications within a month of checking out of the hospital, new research shows.
First Over-the-Counter HIV Test Approved
July 3, 2012
The first over-the-counter test to detect antibodies to the virus that causes AIDS has been approved by the Food and Drug Administration, the agency said Tuesday.
FDA MedWatch Alerts
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