Differences among oral selective serotonin agonists (triptans) are small but clinically relevant for the individual patient, according to a comprehensive meta-analysis.
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Pipeline Preview for January 1, 2002
FDA Actions in Brief as reported January 1, 2002
Although sensitivity analysis is a widely used technique for testing the uncertainty in pharmacoeconomic modeling parameters, it does have limitations. This month's column introduces probabilistic sensitivity analysis as an alternative method for examining uncertainty.
Tenofovir disoproxil fumarate (Viread) recently gained accelerated FDA approval. It is the first member of a new antiretroviral class and also the first antiretroviral approved on the basis of efficacy trials conducted almost exclusively in treatment-experienced patients. This Focus article reviews these studies and considers how other pending and planned trials may refine tenofovir's role.
Like their older counterparts, the newer anticonvulsants gabapentin, lamotrigine, and topiramate show promise for treating various off-label psychiatric and neurologic disorders. This review examines the quality of current evidence for these new uses, identifies where gaps in the evidence lie, and discusses which emerging uses of individual agents appear most justified.
Clinicians at Nebraska Methodist Hospital, a not-for-profit acute care facility, developed and implemented an automatic interchange program for the ACE inhibitor class of drugs. This article presents the ACE inhibitor review upon which the formulary decisions were based as well as the initial clinical and economic results of the interchange program. (This pdf version includes an appendix that was not included in the print issue)
A once-daily, extended-release form of the amphetamine and dextroamphetamine mixture Adderall (Adderall XR, Shire) has been approved for treatment of attention-deficit/hyperactivity disorder. The new product is supplied in capsules that provide double-pulsed amphetamine delivery, prolonging the amphetamine release compared with immediate-release Adderall.
Fondaparinux, the first in a new class of antithrombotics that selectively target factor Xa, has been deemed approvable by the FDA for prevention of venous thromboembolism following orthopedic surgery. Four phase III trials have suggested that it may be more effective than enoxaparin in this setting with little to no additional bleeding risk. This Focus review examines data from these trials and others in an effort to sketch out this pending agent's likely therapeutic role.
New Formulations/Combinations: Pediatric-specific albuterol formulation; fixed-dose bronchodilator combination
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New Indication: Light-activated ophthalmic cleared for CNV due to two additional causes
New Indication: Injectable PPI cleared for hypersecretion due to Zollinger-Ellison syndrome
NMEs/biologics:First nucleotide analog for treatment of HIV-1 infection; dosed once daily
NMEs/biologics: 5-HT receptor agonist for Tx of migraine
Uncle Sam is poised to authorize more than $1 billion to buy medicines and vaccines for the national pharmaceutical stockpile, and federal agencies are gearing up to spend millions more on research related to infectious disease. In response, the pharmaceutical industry is assessing how these developments may alter the way it does business.
Pipeline Preview for December
FDA actions in brief reported November 1, 2001
In less than 2 weeks after the launch of generic fluoxetine in August, Merck-Medco had switched 85% of its mail-order Prozac prescriptions to generic versions of the antidepressant. It says its generic switch rate for retail Prozac scripts was 69% over the same time period.
The September 11 terrorist attacks and October's wave of anthrax cases have forced hospitals and health systems to examine their emergency preparedness from a new perspective. When it comes to planning for possible shortages of critical drugs and the need for biodefense, experts say the right mix of federal guidance and local implementation is key.
Combination use with ribavirin for chronic hepatitis C
Harvard Pilgrim HealthCare, Wellesley, MA-It's well accepted that the provision of drug samples influences physician prescribing practices. Annually, the pharmaceutical industry provides billions of dollars worth of drug samples to physicians' offices and studies have shown the effectiveness of sample medications in shaping physician prescribing patterns.
New Formulations/Combinations: Hormonal vaginal contraceptive ring
New Formulations/Combinations: Oral form of corticosteroid for Tx of mild to moderate Crohn's disease
New Indication: Maintenance treatment of COPD
New Indication: Hepatitis B indication expanded to pediatric patients
NMEs/biologics:Cephalosporin for various infections
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