FDA approves regorafenib tablets for treatment of metastatic colorectal cancer
September 27th 2012FDA approved regorafenib (Stivarga, Bayer HealthCare) tablets for the treatment of patients with metastatic colorectal cancer (mCRC) who have been previously treated with currently available therapies (including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and if KRAS wild type, an anti-EGFR therapy).
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FDA grants priority review to opioid-induced constipation indication for lubiprostone
September 26th 2012FDA has given priority review to an additional indication for lubiprostone (Amitiza, Sucampo Pharmaceuticals and Takeda) for the treatment of opioid-induced constipation (OIC) in patients with chronic, non-cancer pain.
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FDA approves aflibercept injection for macular edema following central retinal vein occlusion
September 24th 2012FDA has approved aflibercept (Eylea, Regeneron) injection for the treatment of macular edema following central retinal vein occlusion (CRVO). The recommended dose for Eylea is 2 mg every 4 weeks (monthly).
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FDA issues safety alert on Intestinomicina marketed as treatment for infectious diarrhea
September 18th 2012FDA is warning consumers not to use Intestinomicina (Laboratorios Lopez), a drug product manufactured in El Salvador and marketed as a treatment for infectious diarrhea and acute gastrointestinal infections. Consumers who have purchased this product should immediately stop taking it and consult with a healthcare provider.
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FDA's CRDAC recommends against approving lixivaptan
September 13th 2012FDA's Cardiovascular and Renal Drugs Advisory Committee recommended against approving lixivaptan (CRTX 080, Cornerstone Therapeutics), for the treatment of symptomatic hypervolemic and euvolemic hyponatremia associated with heart failure and syndrome of inappropriate antidiuretic hormone, respectively.
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Azilsartan medoxomil-chlorthalidone fixed combination superior at reducing SBP
September 10th 2012A fixed-dose combination of azilsartan medoxomil plus chlorthalidone (Edarbyclor, Takeda) was statistically superior to azilsartan medoxomil coadministered with hydrochlorothiazide at reducing and maintaining systolic blood pressure, according to the results of a phase 3 study published online August 31 in The American Journal of Medicine.
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FDA panel backs tobramycin inhalation powder for patients with cystic fibrosis
September 6th 2012An FDA advisory panel voted 13 to 1 that there was adequate evidence of efficacy and safety to support the use of tobramycin inhalation powder (Novartis) for the management of cystic fibrosis patients whose lungs contain bacteria called Pseudomonas aeruginosa.
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Medicare Part D plans control drug spending
September 4th 2012The Medicare Part D prescription drug program has emerged as the poster child for how private plans can control costs while providing quality care. Even critics of health insurers acknowledge that the drug benefit has been a success.
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