McNeil issues wholesale, retail level recalls
November 29th 2010In consultation with FDA, McNeil Consumer Health, Division of McNeil-PPC Inc., has initiated a wholesale and retail level recall of Tylenol Cold Multi-Symptom liquid products; Children?s Benadryl Allergy Fastmelt Tablets, in cherry and grape flavors; Junior Strength Motrin Caplets, 24 count; and Rolaids Extra Strength Softchews, Cherry Flavor 36-count package.
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Manufacturer agrees to withdraw propoxyphene from the market
November 19th 2010Xanodyne Pharmaceuticals has agreed to withdraw propoxyphene (Darvon and Darvocet) from the US market at the request of FDA. FDA also has informed generic manufacturers of Xanodyne?s decision, and they will be removing products containing propoxyphene from the market as well.
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FDA approves denosumab for prevention of SREs in patients with bone metastases from solid tumors
November 19th 2010FDA has approved denosumab (Xgeva, Amgen), the first and only RANK Ligand inhibitor for the prevention of skeletal-related events (SREs) in patients with bone metastases from solid tumors. Xgeva was approved following a 6-month priority review by FDA. Xgeva is not indicated for the prevention of SREs in patients with multiple myeloma.
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Aetna chairman Ron Williams to retire, Mark T. Bertolini to become CEO
November 15th 2010Aetna Chairman and CEO Ronald A. Williams will retire from Aetna in April 2011. On Nov. 29, 2010, Mark T. Bertolini will be appointed chief executive officer and elected to the company?s Board of Directors.
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UnitedHealthcare pilots new cancer care payment model
November 15th 2010UnitedHealthcare (UHC) is working with five medical oncology groups around the country to advance a new cancer-care payment model that reimburses participating medical oncologists upfront for an entire cancer treatment program.
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First IV formulation for acetaminophen approved
November 3rd 2010FDA has approved acetaminophen injection (Ofirmev, Cadence Pharmaceuticals), the first intravenous (IV) formulation of acetaminophen for the management of mild-to-moderate pain, moderate-to severe-pain with adjunctive opioid analgesics, and the reduction of fever.
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Focus on lurasidone: A new atypical antipsychotic for the treatment of schizophrenia
November 1st 2010Lurasidone, a new-generation atypical antipsychotic, has been approved by FDA for the treatment of schizophrenia and is under investigation for the treatment of bipolar disorder. This article will discuss the clinical pharmacology, clinical trials, adverse events, drug interactions, dosing and administration, and formulary considerations.
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New combination: Aliskiren and amlodipine (Tekamlo) have been recently approved by FDA as an initial therapy to treat hypertension in patients likely to need multiple drugs to achieve their blood pressure goals, in hypertensive patients not adequately controlled with monotherapy, or as a substitute for its individual components.
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New agent development crucial in treatment of hepatitis C
November 1st 2010The protease inhibitors boceprevir and telaprevir, in phase 3 development, are poised to become a new therapeutic category of medications to be added to the current standard of care to increase sustained virologic response rates and prevent liver disease in patients with hepatitis C.
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PCORI now has a chairman and board representing all stakeholders to take on the daunting task of setting the national CER agenda, developing systems for funding research, establishing standards and methods for comparative studies, and devising programs to disseminate results to practitioners and to the public.
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