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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 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.
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. |
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