In 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.
Xanodyne 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.
FDA 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.
FDA has approved Lisdexamfetamine dimesylate (Vyvanse, Shire) capsules CII for the treatment of attention deficit hyperactivity disorder (ADHD) in adolescents aged 13 to 17 years.
Aetna 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.
Seven large employers, including six Fortune 500 companies and one state, have launched Catalyst for Payment Reform (CPR
UnitedHealthcare (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.
FDA has to address multiple technical and legal issues to bring similar versions of biotech therapies to market.
FDA 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.
Agents in late-stage development for the treatment of multiple sclerosis.
Lurasidone, 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.
This article will discuss the diagnosis and treatment of ADHD in adults including stimulant therapy, education and psychosocial intervention, and nonstimulant alternatives.
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.
The 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.
Recent FDA Approvals (through October 2010) related to Latuda, Ofirmev, Cymbalta, Botox, Pradaxa, Afinitor, Teflaro, Herceptin, Kapvay
New combination: Olmesartan medoxomil, amlodipine, and hydrochlorothiazide (Tribenzor) 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.
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.
Generic drugs approved by FDA (through October 2010): Extended-release suspension containing hydrocodone polistirex and chlorpheniramine polistirex
Recent FDA action (through, October 2010) related to Qnexa, Linjeta, JZP-6, Bydureon, Zalbin, Staccato loxapine, Tapentadol extended-release oral analgesic, AVP-21D9, 1% tenofovir vaginal gel, AFM 13, hGH-CTP, Rozrolimupab, Nefecon, SB1518 JAK2 inhibitor.
Congress has enacted legislation mandating notice to individuals whose personal information has been compromised
When it comes to insurance, the latest figures from the U.S. Census Bureau show 2009 was a year of superlatives, and none of them good.
New worries should not distract executives from addressing rising costs and threats of consolidations
The federal government is out to change the nature of healthcare from reactive to proactive
HHS is providing some breathing room before employers and insurers have to meet new requirements
The most powerful person in the nation's healthcare system made a heartfelt call for industry assistance in reforming healthcare.
Employers are beginning to focus on price in the broader context of value according to industry analysts
New regulations challenge Medicare Advantage products, but HealthSpring is relying on the future outlook for larger plans in the MA market
The adoption of healthcare reform has created an environment that encourages insurers, health plans, hospitals and clinicians to seek common ground
California is making a statement as the first state to create an oversight board for insurance exchanges, in compliance with the requirements established by the Patient Protection and Affordable Care Act
Many of the estimated 5.1 million Americans with Alzheimer's disease also have other serious medical conditions
