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Newsletter
Vol 92 - April 2012
Featured News
Monthly News Round Up - April 2012
April 2012
Stendra: Another Option for Erectile Dysfunction is Approved Joining the ranks of Viagra (silenafil), Cialis (tadalafil), and Levitra (vardenafil), another phosphodiesterase type 5 (PDE5) inhibitor for erectile dysfunction (ED) by the brand name of Stendra (avanafil) has been approved by the U.S. Read more...
New Drug Approvals
The following drugs have recently been approved by the FDA.
Date of Approval: April 27, 2012
Treatment for: Erectile Dysfunction
Stendra Drug Information | Press Release
Date of Approval: April 6, 2012
Treatment for: Diagnostic
Amyvid 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 6, 2012
Now Approved: Data Showing Superior Efficacy When Compared to Januvia
Victoza Drug Information | Press Release
Labeling Revision Approved: April 26, 2012
now Approved for: Renal Angiomyolipomas associated with Tuberous Sclerosis Complex
Afinitor Drug Information | Press Release
Labeling Revision Approved: March 29, 2012
Now Approved: Pregnancy Category B
Levemir Drug Information | Press Release
New Indication Approved: April 26, 2012
Now Approved for: Advanced Soft Tissue Sarcoma
Votrient Drug Information | Press Release
New Indication Approved: April 2, 2012
Now Approved for: Advanced Parkinson's Disease and Restless Legs Syndrome
Neupro Drug Information | Press Release
New Indication Approved: April 27, 2012
Now Approved for: Plague
Levaquin 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.
Ziprasidone Hydrochloride Tablets
20 mg (base), 40 mg (base), 60 mg (base) and 80 mg (base)
Approved: March 2, 2012 - Lupin Pharmaceuticals, Inc.; Apotex Corp.; Dr. Reddy's Laboratories Limited
Generic for: Geodon
Escitalopram Oxalate Tablets
5 mg (base), 10 mg (base) and 20 mg (base)
Approved: March 14, 2012 - Teva Pharmaceuticals, USA
Generic for: Lexapro Tablets
Escitalopram Oxalate Oral Solution
5 mg (base)/5 mL
Approved: March 14, 2012 - Amneal Pharmaceuticals LLC
Generic for: Lexapro Oral Solution
Ibandronate Sodium Tablets
150 mg (base)
Approved: March 19, 2012 - Apotex Inc.; Mylan Pharmaceuticals Inc.; Orchid Healthcare
Generic for: Boniva
Quetiapine Fumarate Tablets
25 mg (base), 50 mg (base), 100 mg (base), 150 mg (base), 200 mg (base), 300 mg (base) and 400 mg (base)
Approved: March 27, 2012 - Dr. Reddy's Laboratories Limited; Teva Pharmaceuticals, USA; Roxane Laboratories, Inc.; Mylan Pharmaceuticals Inc.; Apotex Corp.; Aurobindo Pharma Limited; Torrent Pharmaceuticals Limited; Lupin Pharmaceuticals Inc.; Sun Pharmaceutical Industries; Accord Healthcare Inc.
Generic for: Seroquel
FDA Drug Safety Labeling Changes
This is a summary of the FDA drug labeling changes for March 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
Atacand HCT
(candesartan cilextetil/hydrochlorothiazide) Tablets
x - x x - - - -
Benicar
(olmesartan medoxomil) Tablets
x - x x - - - -
Sporanox
(itraconazole) Oral Solution
x x x x x - - -
Twynsta
(telmisartan/amlodipine) Tablets
x - x x - - - -
Zestoretic
(lisinopril/hydrochlorothiazide) Tablets
x - x x - - - -
Zestril
(lisinopril) Tablets
x - x x - - - -
Benlysta
(belimumab)
- - x x x - - -
Celexa
(citalopram hydrobromide) Tablets and Oral Solution
- - x x - - - -
Enablex
(darifenacin) Extended-Release Tablets
- - x x - - - -
Incivek
(telaprevir) Film-Coated Tablets
- - x x - - - -
Janumet
(sitagliptin and metformin fixed-dose combination) Tablets
- - x x - - - -
Januvia
(sitagliptin) Tablets
- - x x - - - -
Kombiglyze XR
(saxagliptin/metformin hydrochloride extended-release) Tablets
- - x x - - - -
Lidocaine in 5% Dextrose Injection, USP
- - x - x - - -
Magnevist
(brand of gadopentetate dimeglumine) Injection and Pharmacy Bulk Package
- - x x x - - -
Revlimid
(lenalidomide) Capsules
- - x x - - - -
Reyataz
(atazanavir sulfate) Capsules
- - x x - - - -
Treximet
(sumatriptan and naproxen sodium) Tablets
- - x - - - - -
Votrient
(pazopanib) Tablets
- - x x x - - -
Zometa
(zoledronic acid) Injection
- - x x x - - -
Zmax
(azithromycin extended release) for Oral Suspension
- - x x - - - -
AmBisome
(amphotericin B) liposome for Injection
- - - x x - - -
Amerge
(naratriptan) Tablets
- - - x - - - -
Imitrex
(sumatriptan) Nasal Spray and Tablets
- - - x - - - -
Mobic
(meloxicam) Tablets and Oral Suspension
- - - x - - - -
Prandin
(repaglinide) Tablets
- - - x - - - -
PrandiMet
(repaglinide/metformin HCl fixed-dose combination) Tablets
- - - x - - - -
Ditropan
(oxybutynin chloride) Tablets
- - - - x - - -
Ditropan XL
(oxybutynin chloride) Extended Release Tablets
- - - - x - - -
Invanz
(ertapenem) for Injection
- - - - x - - -
Ketalar
(ketamine HCl) for Injection
- - - - x - - -
Lasix
(furosemide) Tablets
- - - - x - - -
Lumigan
(bimatoprost ophthalmic solution)
- - - - x - - -
Pristiq
(desvenlafaxine) Extended-Release Tablets
- - - - x - - -
Razadyne
(galantamine hydrobromide) Tablets, Oral Solution
- - - - x - - -
Razadyne ER
(galantamine HBr) Extended-Release Capsules 
- - - - x - - -
Sandostatin
(octreotide acetate) Injection
- - - - x - - -
Xalatan
(latanoprost ophthalmic solution)
- - - - x - - -
Novantrone
(mitoxantrone) Injection
- - - - - - - -
Ziagen
(abacavir sulfate) Tablets and Oral Solution
- - - - - - - -
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
U.S. Sees Tripling of Babies Born Addicted to Painkillers
April 30, 2012
About one baby an hour is born addicted to powerful painkillers called opiates in the United States, a new study shows.
Children Usually Excluded From Clinical Drug Trials: Study
April 30, 2012
Children are more likely than adults to suffer from a number of diseases, but few clinical trials are conducted to test new drugs in children with these conditions, researchers have found.
Parents' Poor Math Skills May = Medication Errors
April 28, 2012
Parents with poor math skills are more likely than others to give incorrect doses of medicine to their children, a new study finds.
Rate of Statin-Linked Muscle Woes Unclear, Study Suggests
April 27, 2012
It's been long known that people on high doses of statins, cholesterol-lowering medications taken by millions of Americans, are at risk for a rare yet serious muscle condition.
Some Schools Don't Let Kids Carry Asthma Inhalers
April 27, 2012
Although all 50 states have laws that allow children with asthma to carry inhalers at school and 48 states have laws that let youngsters carry epinephrine pens for serious allergies, experts say that some kids are still being denied access to these lifesaving medications during the school day.
Migraine Guidelines: What Works, What Doesn't
April 23, 2012
Dozens of medications are available to prevent debilitating migraine headaches, but most migraine sufferers don't use them, a new study finds.
Shingles Vaccine Safe, Underutilized, Study Says
April 23, 2012
The shingles vaccine is generally safe and well tolerated by patients, according to a new study.
HIV Prevention Pill Cost-Effective for High-Risk Men: Study
April 17, 2012
A once-a-day pill to prevent HIV infection could significantly reduce the spread of the AIDS-causing virus, but would only be cost-effective if limited to men at very high risk for HIV infection, according to a new study.
Experimental Pill for Multiple Sclerosis Shows Promise
April 16, 2012
An experimental pill reduced the number of lesions in the brains of people with multiple sclerosis (MS), researchers report.
'Off-Label' Drug Use Appears Common
April 16, 2012
Off-label prescribing of medications is common, but the practice varies according to drug, and patient and doctor characteristics, a Canadian study finds.
FDA Adds New Side Effects to Finasteride Label
April 13, 2012
From Associated Press (April 12, 2012) The Food and Drug Administration on Thursday expanded the warning label on the drug finasteride, which is used to treat enlarged prostate and male pattern baldness, saying some men who took the drug continued to have sexual side effects after they stopped taking it.
Breast Cancer Treatment Side Effects May Last for Years
April 11, 2012
Treatment-related complications are common in breast cancer patients long after their therapy has been completed, a new study says.
Urinary Incontinence Drugs May Be More Trouble Than They're Worth
April 9, 2012
For women with urinary incontinence, the available treatments may cause more problems than they solve and many stop taking the medications because of side effects that can include dry mouth and constipation, a new analysis indicates.
Treat Rheumatoid Arthritis Early and Aggressively: Guidelines
April 5, 2012
More aggressive treatment for people in the early stages of rheumatoid arthritis (RA) is among the most important changes recommended in updated American College of Rheumatology treatment guidelines.
Depo-Provera Birth Control Might Raise Breast Cancer Risk
April 4, 2012
There appears to be a link between an injectable form of progestin-only birth control, best known as Depo-Provera, and an increased risk of breast cancer in young women, new research suggests.
Early Study Hints That Breast Cancer Vaccine Might Work
April 2, 2012
A vaccine to prevent breast cancer's return in women with a history of the disease has triggered the desired immune response in early research.
FDA MedWatch Alerts
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