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PebbleBeach.MD FDA Approvals...

FDA: 6 French Engage Introducer Devices Recalled
Class I recall issued due to risk of a potentially life-threatening bleeding episode
Ella Emergency Contraceptive Approved
Intended to inhibit or delay ovulation
FDA: Aseptic Meningitis Risk Related to Lamictal Use
Forty cases of the disease associated with the drug identified through November 2009
FDA: Nimodipine Should Never Be Administered Intravenously
Agency reminds providers that IV use may lead to cardiac arrest, other adverse events, death
FDA: NeoProfen Recalled Due to Visible Particulate Matter
Lundbeck Inc. recalls two lots of the drug, which may result in temporary product shortage
Flu Vaccine for Upcoming Season Approved
Protects against three strains predicted to be most prevalent
FDA: Daptomycin May Increase Eosinophilic Pneumonia Risk
Agency has requested that manufacturer add information about potential risk to drug's label
FDA: Evamist Tied to Adverse Effects in Children, Pets
Agency warns women using estradiol transdermal spray to minimize children's, pets' exposure
Cuvposa Approved for Chronic Drooling in Children
Primarily those with neurological disorders
Combination Drug Approved for High Blood Pressure
Tribenzor sanctioned for those who don't respond to other drugs
Generic Lovenox Approved for Deep Vein Thrombosis
A condition that could cause deadly blood clots
FDA: Antirheumatic Drug Gets New Boxed Warning
Information on severe liver injury added to boxed warning of leflunomide
FDA: Off-Label Use of Malaria Drug Tied to Serious Effects
Quinine sulfate often used off-label to treat or prevent nighttime leg cramps
FDA: Cepheid Recalls MRSA/SA Blood Culture Assay
Products may generate infrequent rates of false negative MRSA results
'Miniature Telescope' for Eye Approved for Macular Degeneration
Implanted device replaces eye's natural lens
Generic Effexor XR Approved
To treat major depressive disorder
Rapid Test to Detect Hepatitis C Approved
OraQuick HCV can detect viral antibodies in about 20 minutes
Dulera Inhaler Approved for Asthma
For people 12 and older
Newly Approved HIV Test Can Spot Infection Earlier
Detects both HIV antigen and antibodies
Tasigna Approval Widened to Include Early Stages of Rare Leukemia
But users are at greater risk of heart disorder

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