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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 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.
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. |
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