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U.S. Food and
Drug Administration
FDA Consumer magazine
March-April 2001
Table of Contents
From drugs that bring relief to devices that detect disease, many products approved in the year 2000 represent important advances in the prevention, diagnosis, and treatment of serious conditions. Last year, the Food and Drug Administration approved 160 new drugs, biological products, and medical devices.
Three of FDA's centers--the Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research (CBER), and the Center for Devices and Radiological Health (CDRH)--give premarket approval for new health-care products. They also prevent unsafe or ineffective products from going on the market, assure adequate labeling for approved products, and monitor the effects of marketed therapeutics.
FDA's Center for Drug Evaluation and Research (CDER) issued 98 approvals for original new drug applications in the total median time of 11.2 months. The Center for Biologics Evaluation and Research (CBER) issued 13 approvals for product license or biological license applications in the median time of 25.1 months. The Center for Devices and Radiological Health (CDRH) approved 49 product marketing applications for original devices in the median time of 9.6 months. CDRH approved four additional products under FDA's Humanitarian Use Exemptions program (for devices with a patient population up to 4,000) in a median time of 3.5 months
Along with approving 98 original new drugs, CDER issued 244 approvals for generic versions of drugs on which the patents had expired. FDA approved 20 products classified as priority drugs in a median time of six months. And FDA approved 27 new molecular entities (products with ingredients never before marketed in the United States) in the median time of 15.6 months. Along with approving a host of important new medical products in 2000, FDA has continued to exceed virtually all of its performance goals under the Prescription Drug User Fee Act.
In addition to approving 53 original new medical devices, CDRH cleared for the market 3,457 so-called 510(k) devices. These are products similar to devices already in use. CBER issued 13 approvals for product license or biological license applications.
Among the important products that passed FDA's rigorous review for safety and effectiveness are Zyvox (linezolid), the first of a new class of antibacterial drugs that addresses the emerging public health threat of vancomycin-resistant bacterial infections. Vancomycin has been the treatment of last resort for an organism called Enterococcus faecium for many years.
And the approval of Visudyne (verteporfin for injection) brought the first therapy to slow vision loss in people with wet age-related macular degeneration, a condition that annually causes blindness in one million Americans over age 55.
Among the significant medical devices approved by FDA was the Da Vinci Surgical System, which uses cutting-edge robotics technology to perform laparoscopic gall bladder and reflux disease surgery. The Cordis Checkmate System and Novoste Beta Cath System are approved devices that use catheters to deliver radiation inside a coronary stent after a blocked artery is reopened. The radiation helps reduce the risk of repeated narrowing of the artery.
In addition to elderly patients and those with heart disease, children, women, and patients with cancer are among the groups that particularly benefit from FDA approvals in 2000. Here are some examples:
FDA approved an unusually high number of health-care products for children. In recent years, Congress and FDA have stimulated increased pediatric submissions by offering limited pediatric exclusivity to manufacturers who conduct studies for pediatric use of their products. Several new products were either designed for the youngest patients or were adult drugs with pediatric indications.
The OxiFirst Fetal Oxygen Saturation Monitoring System represents the first major technological development in fetal monitoring in three decades. The system measures oxygen saturation in a baby's blood as a sign of fetal health during labor and delivery. FDA also approved Prevnar, a vaccine to prevent invasive pneumococcal diseases that can cause brain damage and death. The vaccine is the first of its kind for infants and toddlers under age 2.
Children with asthma can benefit from last year's approval of Pulmicort Respules (budesonide inhalation suspension), the first anti-inflammatory corticosteroid for inhalation using a nebulizer in this age group. This is an important feature because toddlers frequently cannot use metered-dose inhalers. FDA approved Relenza (zanamivir) to treat uncomplicated influenza A and B in patients age 7 and up. And Tamiflu (oseltamivir phosphate) oral suspension received approval for the prevention of the influenza virus in patients 13 and older. Influenza causes 20,000 deaths and 100,000 hospitalizations a year.
Examples of drugs approved last year that had both adult and pediatric indications are Kaletra, a combination of lopinavir and ritonavir, which received accelerated approval for HIV treatment; Unithroid (levothyroxine sodium), a thyroid replacement drug; and Protopic (tacrolimus), an ointment that treats moderate to severe eczema. FDA also added pediatric use to the labeling of 13 adult medications, including ibuprofens Motrin and Advil, and Zantac (ranitidine) for stomach acid reflux. And the agency approved lowering the age for the Nucleus 24 Cochlear Implant from 18 months to 12 months for infants who are profoundly hearing-impaired.
Three-quarters of the more than 8 million Americans with rheumatoid arthritis are women. FDA approved Remicade (infliximab) to treat rheumatoid arthritis in patients with inadequate response to methotrexate. Another approval that primarily benefits women is Novantrone (mitoxantrone hydrochloride), a cancer drug, to treat advanced or chronic multiple sclerosis. This disease affects up to 350,000 Americans, most of whom are women.
FDA also approved Mifeprex (mifepristone) for the termination of pregnancy within 49 days from the beginning of the last menstrual period. And following clinical studies involving 9,000 women, the agency also allowed continued marketing of two types of saline-filled breast implants that are approved for breast augmentation and breast reconstruction in women 18 years or older.
FDA approved three medical devices last year to help fight cancer, the second deadliest disease in the United States, affecting eight million Americans. The Optical Biopsy System is a laser system that helps doctors distinguish small, harmless growths from precancerous growths in the colon.
The Senographe 2000D is a mammography system that produces digital images. Unlike radiographic film, digital images can be electronically stored and transferred so specialists can evaluate them at a remote location. The images can also be manipulated to correct for under- or over-exposure. Early diagnosis remains the best weapon against breast cancer, which annually affects 185,000 women, 46,000 of whom die of the disease.
The third device in this category is the FocalSeal-L Surgical Sealant, approved for sealing air leaks in lungs following the removal of cancerous tumors. Light activates the sealant, which is "painted" on the lung. FDA reviewed the sealant on an expedited basis because of its potential importance for patients with lung cancer.
As for cancer medications, two-Trisenox and Mylotarg-were approved for cancers of the white blood cells. Trisenox (arsenic trioxide) was found safe and effective to treat acute promyelocytic leukemia (APL) in patients who have not responded to, or have relapsed following all trans-retinoic acid and anthracycline-based chemotherapy. Trisenox, a priority drug, was approved in six months. The product's total development time was only three years.
Other FDA approvals designed to benefit patients with cancer included Mylotarg (gemtuzumab ozogamicin) for the treatment of CD33 positive acute myeloid leukemia for patients 60 years or older who have relapsed for the first time and are not suitable candidates for the standard cytotoxic therapy. FDA also approved Novaldex (tamoxifen citrate) to reduce risk of invasive breast cancer for women with preinvasive cancer of the ducts.
(Infographic by Renée Gordon)
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