FDA actions in brief reported November 1, 2001
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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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NMEs/biologics: Longer-lasting erythropoietin product for anemia related to renal failure
With the government spending billions to fight terrorism at home and abroad, federal investigators are looking closely at all health care programs for opportunities to stymie abuses and collect big penalties.
Pipeline Preview for November
Interferon alfa-2b and the nucleoside analog lamivudine are the currently available options for treating chronic hepatitis B virus (HBV) infection. This article reviews major efficacy findings with these agents, defines their role according to patients' clinical status, and provides the latest data on optimal duration of therapy, predictors of response, and long-term effects. The authors also explore the emergence of hepatitis B immune globulin for post-liver transplant HBV prophylaxis and offer a progress report on experimental therapies for chronic HBV infection.
University Hospital and Medical Center (Tamarac)/University of Florida (Gainesville)-Dalteparin appears to be at least as clinically effective as enoxaparin for the prevention or treatment of the consequences of venous and arterial thromboembolic diseases, say clinicians from these two facilities.
FDA actions In Brief as reported October 1, 2001
New Formulations/Combinations: Fixed-dose analgesic combination for short-term acute pain management
New Indication: Combination use with docetaxel for breast cancer; new black box
New Indication: Antiepileptic cleared for Lennox-Gastaut syndrome; glaucoma warning added
New Indication: Oral contraceptive approved for acne
New Indication: Low-dose t-PA for catheter clearance
NMEs/biologics:Short-infusion bisphosphonate for hypercalcemia of malignancy
FDA Pipeline Preview
Market share shift analysis identifies scenario allowing maximum number of ED patients to be treated
Minneapolis Veterans Administration Medical Center-Decreasing or eliminating the use of alprostadil-based erectile dysfunction treatments and converting to 100% sildenafil use would save this VA medical center more than $101,000 annually. Furthermore, the projected savings would allow an additional 405 men with erectile dysfunction to be treated for an entire year, say clinicians at this facility.
Patients' adherence ability is by far the top patient factor guiding selection of a first-line antiretroviral regimen for HIV, according to a new physician survey.
For the first time, a large clinical trial has shown that a medication can help prevent type 2 diabetes in high-risk individuals. At the same time, drug therapy emerged as a less effective preventive strategy than fairly modest diet and exercise changes.
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