News

FDA issued a complete response letter to EMD Serono, an affiliate of Merck KGaA, requesting additional information on cladribine (Movectro), a drug intended for the treatment of relapsing-remitting multiple sclerosis.

A recent recall of generic warfarin tablets was expanded to include 6 other drug products prepared on the same packaging line.

In mid February, US Marshals acting on a request of FDA seized all lots of Auralgan Otic Solution from Integrated Commercialization Solutions in Brooks, Ky.

Agents in late-stage development for the treatment of rare cancers.

Recent FDA action (through, February 2011) related to Contrave, rabeprazole sodium extended-release capsules, Avodart, Mu Delta, Carfilzomib, Vascugel, INX-0818, vosaroxin, Acurox, fidaxomicin, melanoma cancer vaccine, NSI-566RSC, Regorafenib.

New formulation: Fentanyl sublingual tablets were approved by FDA to manage breakthrough pain in patients aged ?18 years who are already receiving and tolerant to opioids for their underlying persistent cancer pain.

Generic drugs approved by FDA (through February 2011): Galantamine hydrobromide

The active drug safety surveillance system being established by FDA promises to do more than obtain timely adverse event information on marketed medicines.

New molecular entity: Vilazodone hydrochloride tablets were approved by FDA on January 21, 2011, for the treatment of major depressive disorder in adults.

Recent FDA Approvals (through February 2011) related to Edarbi, Gralise, Rituxan, Menveo, Makena, Corifact, Epicyn HydroGel

In recent years there has been an explosion of new investigations into the pathophysiology of bipolar disorder and its medication therapies. This article will review current, emerging, and controversial therapies for the treatment of bipolar disorder, specifically the mania aspect.

Ceftaroline has demonstrated activity against methicillin-resistant Staphylococcus aureus and multidrug-resistant Streptococcus pneumoniae as well as common respiratory Gram-negatives including Haemophilus, Moraxella, and Klebsiella species.

With the vote to repeal the Patient Protection and Affordable Care Act behind them, many Congressional leaders are focusing instead on ways to repair or eliminate some of the more contentious reform provisions.

Care for the roughly 9 million dual eligibles in this country tends to be fragmented with Medicare and Medicaid engaging in cost shifting, resulting in a lack of accountability.

FDA has approved the first drug to help prevent premature birth before 37 weeks of pregnancy in women who have had at least one previous preterm delivery.

The federal agencies charged with issuing regulations interpreting the law already have started their work.

For the next several years, "consolidation" will be the watchword for the healthcare industry as plans and providers position themselves for the changing market.

Effecting change requires that standards of care are not only implemented, but measured and managed from patient and provider perspectives.

Fewer than a third of Americans consume the recommended five servings of fruits and vegetables per day.

Studying drugs in younger populations is challenging, and the scarcity of pediatric studies limits the ability of doctors and scientists to accurately predict drug dosing, safety and efficacy in children.

Insurance executives are observing a greater degree of anxiety among providers as they try to build their networks in an evolving era of healthcare.

Three entities - the Medicare Independent Payment Advisory Board; Center for Medicare and Medicaid Innovation; and Patient Centered Outcomes Research Institute - are examining payment mechanisms, cost containment and quality of care.

A few states have threatened to shut down Medicaid programs, and some say they won't set up local insurance exchanges if they have to meet all the requirements of the Patient Protection and Accountable Care Act.

The impact and magnitude of expenditures should have made Part D an immediate enforcement priority for the Centers for Medicare and Medicaid Services

Poor thyroid function can be treated through several drug choices.

As risk selection diminishes under health reform, risk adjustment is now becoming a superior tool in a health plan's toolbox.

FDA approved azilsartan medoxomil tablets (Edarbi, Takeda Pharmaceutical North America) to treat hypertension in adults.

Unprecedented levels of drug shortages, especially those drugs for which there are no substitutes, has prompted legislators to take action. Since the inception of the FDA Drug Shortage Program in 2000, the agency has been tracking the nation?s prescription pharmaceuticals and publishing a list of drugs in short supply.

FDA is warning that terbutaline administered by injection or through an infusion pump should not be used in pregnant women for prevention or prolonged (beyond 48-72 hours) treatment of preterm labor because of the risk for serious maternal heart problems and death.

Merck Serono Europe informed the European Medicines Agency that it was withdrawing its marketing authorization application for oral cladribine (Movectro), 10-mg tablets, intended for the treatment of relapsing-remitting multiple sclerosis.