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After months of delay, the Senate confirmed Lester M. Crawford, DVM, PhD, in July as the official head of FDA. Despite efforts by some Senators to hold up the vote pending resolution of some FDA policies, most legislators agreed with Republican and Democratic leaders that the agency would be better off with a permanent chief than without.

Highly resistant strains of both gram-positive and gram-negative bacteria are becoming commonplace in both the inpatient and outpatient setting. Recently developed antimicrobials have targeted resistant gram-positive pathogens, but the problem of resistant gram-negative pathogens remains. Tigecycline (Tygacil, Wyeth) is an injectable antimicrobial and the first in a new class of agents (the glycylcyclines) that possesses activity against key gram-positive and gram-negative bacterial pathogens. Tigecycline overcomes common tetracycline resistance mechanisms and has shown in vitro and in vivo activity against multidrug-resistant organisms. Tigecycline treatment produced clinical and microbiologic outcomes similar to standard comparator agents in patients with complicated skin and skin structure infections and complicated intra-abdominal infections and was approved for these indications in June 2005. The most common adverse events associated with tigecycline's administration during clinical trials were..

FDA actions in brief

FDA approved moxifloxacin (Avelox, Schering-Plough) tablets and injection for the once-daily treatment of adults with complicated skin and skin structure infections (cSSSIs) caused by methicillin-susceptible Staphylococcus aureus, Escherichia coli, Klebsiella pneumoniae, or Enterobacter cloacae.

Rozerem

Efficacy. The efficacy of ramelteon in the treatment of chronic insomnia was evaluated in 2 randomized, double-blind trials employing polysomnography (PSG).

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Alvimopan (Entereg, Adolor/GlaxoSmithKline) for the treatment of postoperative ileus.

As healthcare costs continue to spiral, the search for solutions is reaching a frantic pace. My experiences over the years have led me to believe that while Consumer- Directed Healthcare (CDHC) has entered the mainstream lexicon, it is far from understood.

Prepare for Part D

There also needs to be sufficient access and guidance so the beneficiary can make informed and knowledgeable choices.

Risk Taker

As a third grader, Jean Fraser thought she would become a doctor. Her science class dissected a chicken, and she became so fixated by the experience that she described the process in detail to her father during the family dinner each night. Unbeknown to her until recently, her descriptions back then had made her father sick to his stomach.

Cyclooxygenase-2 (COX-2)-selective nonsteroidal anti-inflammatory drugs (NSAIDs) have been widely prescribed for patients with arthritis and other conditions because of their lower risk for gastrointestinal adverse events compared with nonselective NSAIDs 1,2

Dapoxetine (Alza/Ortho-McNeil) is a novel oral medication undergoing FDA review for premature ejaculation, one of the most common disorders of sexual dysfunction in men. Dapoxetine is a fast-acting inhibitor of the serotonin reuptake transporter. It has a short half-life and is structurally related to the antidepressant fluoxetine, allowing for on-demand dosing.

A study was conducted to determine the cost and patient adher- ence rates of lipid-lowering therapy with an extended-release niacin and lovastatin (ERNL) combination agent versus a separate extended-release niacin and statin (ERN-S) combination or statin monotherapy.

The objective of this study was to track the utilization of anti-inflammatory drugs among patients with active rofecoxib prescriptions at the time of market withdrawal through retrospective analysis of pharmacy records and to assess the need for COX-2 inhibitor therapy due to gastrointestinal risk factors.

Best practices indicate that health benefits are continued during employee and CEO transitions

In The Sprawling Surroundings of Oklahoma City sits a microcosm of what many stakeholders want for healthcare's future. The Oklahoma Heart Hospital, a 78-bed cardiac specialty hospital, offers the latest in high-tech medicine complemented by high-touch patient care.