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Newsletter
Vol 93 - May 2012
Featured News
Monthly News Round Up - May 2012
May 2012
Elelyso Approved for Rare Type 1 Gaucher Disease Type 1 Gaucher disease occurs in roughly 6,000 people in the United States. Read more...
New Drug Approvals
The following drugs have recently been approved by the FDA.
Date of Approval: May 17, 2012
Treatment for: Pancreatic Exocrine Dysfunction
Pertzye Drug Information | Press Release
Date of Approval: May 11, 2012
Treatment for: Acne
Fabior Drug Information | Press Release
Date of Approval: May 1, 2012
Treatment for: Gaucher Disease
Elelyso Drug Information | Press Release
Date of Approval: May 1, 2012
Treatment for: Allergic Rhinitis
Dymista 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.
Patient Population Altered: May 18, 2012
Now Approved for: Children 2-5 Years of Age with Type 1 Diabetes
Levemir 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.
Vardenafil Tablets
2.5 mg, 5 mg, 10 mg and 20 mg
Approved: May 3, 2012 - Teva Pharmaceuticals USA
Generic for: Levitra
Carbidopa, Entacapone and Levodopa Tablets
25 mg/200 mg/100 mg and 37.5 mg/200 mg/150 mg
Approved: May 10, 2012 - Sun Pharma Global FZE
Generic for: Stalevo 100 and Stalevo 150
Clopidogrel Tablets
75 mg (base) and 300 mg (base)
Approved: May 17, 2012 - Apotex Inc.; Aurobindo Pharma Limited; Dr.Reddy's Laboratories Limited; Gate Pharmaceuticals; Mylan Pharmaceuticals, Inc.; Roxane Laboratories, Inc.; Sun Pharma Global FZE; Teva Pharmaceuticals, USA Inc.; Torrent Pharmaceuticals Limited
Generic for: Plavix
Ropinirole Hydrochloride Extended-Release
2 mg (base), 4 mg (base), 6 mg (base), 8 mg (base) and 12 mg (base)
Approved: May 17, 2012 - Actavis Elizabeth LLC
Generic for: Requip XL
Butoconazole Vaginal Cream
2%
Approved: May 18, 2012 - Perrigo Israel
Generic for: Femstat 3
Lansoprazole Delayed-Release Capsules
15 mg (OTC)
Approved: May 18, 2012 - Dr.Reddy's Laboratories Limited; Perrigo; Wockhardt Ltd.
Generic for: Prevacid 24HR
Nevirapine Tablets
200 mg
Approved: May 22, 2012 - Apotex Corp.; Aurobindo Pharma Limited; Camber Pharmaceuticals, Inc.; Cipla Limited; Micro Labs Limited; Mylan Pharmaceuticals, Inc.; Prinston Pharmaceutical Inc.; Sciegen Pharmaceuticals
Generic for: Viramune Tablets
Nevirapine Oral Suspension
50 mg/5 mL
Approved: May 22, 2012 - Aurobindo Pharma Limited
Generic for: Viramune Oral Suspension
Dextromethorphan Polistirex Extended Release Suspension
eq 30 mg dextromethorphan hydrobromide /5 mL
Approved: May 25, 2012 - Tris Pharma, Inc.
Generic for: Delsym 12 Hour Cough Relief
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
Genes Might Help Some Smokers Kick the Habit
May 31, 2012
Smokers' genes may help predict whether they'll respond to drug treatments for nicotine addiction, a new study indicates.
Taking Anti-HIV Meds Prior to Exposure May Help Prevent Infection
May 29, 2012
Preventive antiretroviral treatment appears to be an effective way to help protect high-risk people against HIV infection, a new study suggests.
Common Painkillers May Help Prevent Skin Cancer: Study
May 29, 2012
Taking nonsteroidal anti-inflammatory drugs (NSAIDs) - which include medicine cabinet staples such as aspirin, Motrin and Aleve - appears to significantly lower the risk for developing several major forms of skin cancer, a new Danish study reveals.
Discovery of Gene May Lead to New Male Contraceptive
May 24, 2012
The discovery of a key gene involved in sperm development could eventually lead to the creation of a new type of non-hormonal birth control for men, a study involving mice suggests.
Body Building, Diet Supplements Linked to Liver Damage: Study
May 22, 2012
Body-building and weight-loss products are the types of dietary supplements most likely to cause liver injury, according to a small new study.
More Research Points to Long-Term Ills With Bone Drugs
May 21, 2012
Adding more weight to concerns about possible long-term dangers of osteoporosis drugs, a new study finds that people who take the drugs, known as bisphosphonates, may be at increased risk for atypical fractures of the thigh bone (femur).
Birth Control Pills, HRT Tied to Digestive Ills
May 21, 2012
The use of oral contraceptives by younger women or hormone therapy by older women may be linked with inflammatory bowel disease, new research indicates.
Trial Set to See if Drug Can Prevent Alzheimer's
May 15, 2012
Researchers are preparing to test an experimental drug in people genetically primed to develop Alzheimer's disease.
New Drug Shows Promise for Myeloma Patients
May 9, 2012
Three new studies confirm that the drug lenalidomide can significantly lengthen the time that people with multiple myeloma experience no worsening of their disease, either after having a stem cell transplant or getting chemotherapy.
Germs Behind Urinary Tract Infections Becoming More Resistant to Drugs
May 4, 2012
E. coli bacteria's resistance to ciprofloxacin (Cipro), the most widely prescribed antimicrobial for urinary tract infections in the United States, increased five-fold between 2000 and 2010, according to a new study.
Aspirin as Effective as Warfarin for Heart Failure: Study
May 2, 2012
Aspirin is just as effective as the blood-thinner warfarin in preventing stroke and death in heart failure patients with a normal heart rhythm, a landmark study indicates.
Scientists Spot How Cox-2 Painkillers Raise Heart Risks
May 2, 2012
New research has uncovered how some cox-2 painkillers increase the risk for both heart attacks and stroke.
FDA MedWatch Alerts
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