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Newsletter
Vol 91 - March 2012
Featured News
Monthly News Round Up - March 2012
March 2012
Omontys Approved For Dialysis Patients with Anemia Due to Chronic Kidney Disease The U.S. Read more...
New Drug Approvals
The following drugs have recently been approved by the FDA.
Date of Approval: March 27, 2012
Treatment for: Anemia Associated with Chronic Renal Failure
Omontys Drug Information | Press Release
Date of Approval: March 23, 2012
Treatment for: Allergic Rhinitis
QNASL Drug Information | Press Release
Date of Approval: March 12, 2012
Treatment for: Osteoporosis
Binosto Drug Information | Press Release
Date of Approval: March 6, 2012
Treatment for: Respiratory Distress Syndrome
Surfaxin Drug Information | Press Release
Date of Approval: March 1, 2012
Treatment for: Pancreatic Exocrine Dysfunction
Ultresa Drug Information | Press Release
Date of Approval: March 1, 2012
Treatment for: Pancreatic Exocrine Dysfunction
Viokace 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: March 1, 2012
Now Approved: FluMist Quadrivalent
FluMist Drug Information | Press Release
New Indication Approved: March 14, 2012
Now Approved for: Heavy Menstrual Bleeding
Natazia Drug Information | Press Release
Patient Population Altered: March 26, 2012
Now Approved for: Pediatric Patients
Intelence 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.
Cisatracurium Besylate Injection
2 mg (base)/mL; packaged in 20 mg (base)/10 mL multiple-dose vials
Approved: February 3, 2012 - Sandoz Inc.
Generic for: Nimbex Injection
Cisatracurium Besylate Injection
(Preservative Free) 10 mg (base)/mL packaged in 200 mg (base)/20 mL; and 2 mg (base)/mL packaged in 100 mg (base)/5 mL single-dose vials
Approved: February 3, 2012 - Sandoz Inc.
Generic for: Nimbex Injection
Tizanidine Hydrochloride Capsules
2 mg (base), 4 mg (base) and 6 mg (base)
Approved: February 3, 2012 - Apotex Inc.
Generic for: Zanaflex Capsules
Doxycycline Hyclate Delayed-Release Tablets
USP, 150 mg (base)
Approved: February 8, 2012 - Mylan Pharmaceuticals Inc.
Generic for: Doryx Delayed-Release Tablets
FDA Drug Safety Labeling Changes
This is a summary of the FDA drug labeling changes for February 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
Amturnide
(amlodipine/aliskiren/hydrochlorothiazide) tablets
x - x x x - - -
Benicar
(olmesartan medoxomil) Tablets
x - x x - - - -
Cardiogen-82
(Rubidium Rb 82 Generator)
x - x x - - - -
Letairis
(ambrisentan) Tablets
x x x x x x - -
Tekamlo
(aliskiren/amlodipine) tablets
x - x x - - - -
Tekturna
(aliskiren) and Tekturna HCT (aliskiren/hydrochlorothiazide) Tablets
x - x x x x - -
Valturna
(aliskiren/valsartan) tablets
x - x x - - - -
Vaseretic
(enalapril maleate/hydrochlorothiazide) Tablets
x - x x - - - -
Vasotec
(enalapril maleate) Tablets
x - x x - - - -
Angeliq
(drospirenone and estradiol) tablets
- x x x - - - -
Crixivan
(indinavir sulfate) Capsules
- x x x - x - -
Elestrin
(estradiol gel)
- x x x - - - -
Mevacor
(lovastatin) Tablets
- x x x x - - -
Phendimetrazine tartrate SR 105 mg capsules
- x - x x - - -
Premarin
(conjugated estrogens) Vaginal Cream
- x x x x x - -
Prempro
(conjugated estrogens/medroxyprogesterone acetate tablets) and Premphase (conjugated estrogens plus medroxyprogesterone acetate) tablets
- x x x x x - -
Simcor
(niacin ER/simvastatin) Tablets
- x x x x x - -
Viracept
(nelfinavir mesylate) Oral Powder
- x x x - x - -
Vytorin
(ezetimibe/simvastatin) Tablets
- x x x - - - -
Zocor
(simvastatin) Tablets
- x x x - - - -
Abilify
(aripiprazole) Tablets, Orally Disintegrating Tablets, Oral Solution, and Injection
- - x x - - - -
Aptivus
(tipranavir) Capsules and Oral Solution
- - x x - x - -
Avalide
(irbesartan/hydrochlorothiazide) tablets
- - x x x - - -
Beyaz
(drospirenone/ethinyl estradiol/levomefolate calcium tablets and levomefolate calcium) tablets
- - x x - - - -
Crestor
(rosuvastatin calcium) Tablets
- - x x x x - -
Diovan HCT
(valsartan/hydrochlorothiazide) Tablets
- - x x x - - -
EES
(erythromycin ethylsuccinate) Granules for oral suspension, Eryc (erythromycin delayed-release) capsules, Ery-Ped liquid and
- - x - - - - -
PCE
(erythromycin particles in tablets) 333 mg and 500 mg film coated tablets
- - x - - - - -
Exforge HCT
(amlodipine/valsartan/hydrochlorothiazide) tablets
- - x x x x - -
Famvir
(famciclovir) Tablets
- - x x x - - -
Hepsera
(adefovir dipivoxil) tablets
- - x x - x - -
Invirase
(saquinavir mesylate) Capsules and Tablets
- - x x - x - -
Kaletra
(lopinavir/ritonavir) Tablets and Oral Solution
- - x x - x - -
Lescol
(fluvastatin sodium) Capsules,
- - x x x - - -
Lescol XL
(fluvastatin sodium) Extended-Release Tablets
- - x x x - - -
Lexiva
(fosamprenavir calcium) tablets and oral suspension
- - x x - - - -
Lipitor
(atorvastatin calcium) Tablets
- - x x x x - -
Livalo
(pitavastatin) tablets
- - x x x - - -
Lotensin HCT
(benazepril HCl and hydrochlorothiazide) Tablets
- - x x x - - -
Natazia
(estradiol valerate and estradiol valerate/dienogest) tablets
- - x x - - - -
Norvir
(ritonavir) oral solution and tablets
- - x x - - - -
Orencia
(abatacept) for injection
- - x x - - - -
Ozurdex
(dexamethasone intravitreal) implant
- - x x x - - -
Patanase
(olopatadine hydrochloride) Nasal Spray
- - x x x x - -
Pravachol
(pravastatin sodium) Tablets
- - x x x x - -
Prezista
(darunavir), Oral suspension
- - x x - x - -
Reyataz
(atazanavir sulfate) Capsules
- - x x - - - -
Rituxan
(rituximab) Intravenous Injection
- - x x x - - -
Safyral
(drospirenone/ethinyl estradiol/levomefolate calcium tablets and levomefolate calcium) tablets
- - x x - - - -
Xalkori
(crizotinib) Capsules
- - x x - x - -
Yasmin
(drospirenone/ethinyl estradiol) tablets
- - x x - x - -
Zyvox
(linezoid) Tablets, Oral Suspension
- - x - x - - -
Diovan
(valsartan) Tablets
- - - x x - - -
Kaletra
(lopinavir/ritonavir) Capsules
- - - x - x - -
Norvir
(ritonavir) Capsules
- - - x - x - -
Samsca
(tolvaptan) tablets
- - - x - - - -
Tykerb
(lapatinib) Tablets
- - - x - - - -
Vaprisol
(conivaptan) injection
- - - x - - - -
Vexol
(rimexolone ophthalmic suspension) 1%
- - - x - - - -
Adderall XR
(dextroamphetamine mixed salts of a single-entity amphetamine product) Capsules
- - - - x - - -
Arranon
(nelarabine) injection
- - - - x - - -
Noroxin
(norfloxacin) Tablets
- - - - x - - -
Precose
(acarbose) Tablets
- - - - x - - -
Prograf
(tacrolimus) capsules and injection
- - - - x - - -
Sodium Iodide I-131 Therapeutic Capsules and Therapeutic Solution
- - - - x - - -
Theophylline in 5% Dextrose in the Excel Plastic Container
- - - - x - - -
Januvia
(sitagliptin) tablets (PPI/MG)
- - - - - x - -
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
Warm Weather Triggers Early Allergy Season
March 30, 2012
While unseasonably warm weather delights many people, those with allergies may not be as thrilled with the early arrival of spring.
First Bedside Gene Test Shows Promise
March 29, 2012
For the first time, a genetic test done at a patient's bedside helped doctors choose the right medicine, Canadian researchers report.
Two Experimental Drugs Could Improve Psoriasis Treatment
March 28, 2012
A new type of treatment may be on the horizon for people with moderate to severe cases of the chronic skin condition known as psoriasis.
New Injection Might Lower Tough-to-Treat Cholesterol
March 26, 2012
Researchers report that injections of a novel "monoclonal antibody" lowered LDL cholesterol levels in patients with high cholesterol by as much as 72 percent.
Statin Alternative Looks Promising in Early Trials
March 21, 2012
A new anti-cholesterol drug appears safe and effective in people already taking statins such as Lipitor, making it a potential addition to statin therapy or an alternative, a preliminary new study suggests.
Antibiotics Useless for Most Sinus Infections, Experts Say
March 21, 2012
Most sinus infections are caused by viruses and should not be treated with antibiotics, which target bacteria and are useless against viruses, new expert guidelines state.
More Evidence Shows That Daily Aspirin Might Combat Cancer
March 20, 2012
Aspirin, a popular weapon in the war against heart attacks, may also play a role in cancer prevention and treatment, three new British studies suggest.
Ibuprofen May Ward Off Altitude Sickness
March 20, 2012
The anti-inflammatory and painkiller ibuprofen seems to reduce the risk of altitude sickness, according to a new study.
New Type 2 Diabetes Drug Helps Lower Blood Sugar: Study
March 19, 2012
A new type of medication for type 2 diabetes helps to lower blood sugar levels when used in concert with insulin and other diabetes drugs, new research suggests.
New Gel Treats Precancerous Skin Condition in Days: Study
March 14, 2012
A newly approved gel appears effective in treating a condition called actinic keratosis, which is a common precursor to squamous cell skin cancer, a new study finds.
Experimental Pill May Ease Multiple Sclerosis Disability
March 14, 2012
Yet another orally taken medication shows some promise in preventing relapse and disability for people with relapsing-remitting multiple sclerosis, a new report suggests.
Seniors' Long-Term Use of Strong Painkillers a Concern
March 12, 2012
Older patients prescribed narcotic painkiller drugs, such as codeine or oxycodone, soon after short-stay surgery are at increased risk of becoming long-term users, a new study finds.
Woman's Recovery From Advanced Melanoma Could Help Guide Research
March 7, 2012
Combining the immune-based drug ipilimumab with targeted radiation therapy improved one advanced melanoma patient's ability to fight the deadly skin cancer, a new study says.
Prescription Meds Can Put on Unwanted Pounds
March 2, 2012
Medications taken by millions of Americans for mood disorders, high blood pressure, diabetes and other chronic conditions can have an unhealthy side effect: weight gain.
FDA MedWatch Alerts
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