FDA Approval of the First Generic Ondansetron
Approval has been given by the Food and Drug Administration (FDA) for the first generic versions of Zofran (ondansetron) tablets. Ondansetron is used to prevent nausea and vomiting associated with surgery, radiotherapy, and cancer chemotherapy. According to the press release from the FDA, ondansetron was the 20th highest-selling brand-name drug in the United States in 2005.
The FDA approval is significant for providing patients with lower-cost generic medications. A generic drug is the bioequivalent of a brand-name drug with respect to pharmacokinetic and pharmacodynamic properties. Manufactures of generic drugs are able to sell the generic medicines at reduced prices because they incur fewer costs in creating them. High costs associated with the development of new drugs include costs associated with research and development of the drug, costs associated with obtaining regulatory approval (i.e., proving the safety and efficacy of a drug), and marketing costs. Generic drugs can be legally produced in the case of drugs for which (1) the patent has expired; (2) the generic company certifies that the brand company's patents are either invalid, unenforceable, or will not be infringed; (3) patents have never been held; or (4) no patent is in force.
Some large pharmaceutical companies have begun producing their own generic products before the expiration of their patent, or licensing their own product to be branded by generic companies. The end result is a generic product that actually is the brand product packaged in a different box.
Par Pharmaceutical Companies, Inc. is the manufacturer of ondansetron. Ondansetron will be available in 4- and 8-mg tablets. Par has been awarded 180 days of marketing exclusivity for being the first to file an abbreviated new drug application. Marketing of the drug will be conducted by PLIVA, Inc., a subsidiary of Barr Pharmaceuticals, Inc., Woodcliff Lake, New Jersey.
SOURCE
U.S. Food and Drug Administration. FDA approves first generic ondansetron tablets: Orally disintegrating tablets and oral solution. Retrieved March 19, 2007 from http://www.fda.gov/bbs/topics/NEWS/2006/NEW01539.html
Caregiver Resource Information
http://NetofCare.org contains resource information for family caregivers. According to the site's brochure, a caregiver is identified as "anyone who provides physical or emotional care to relatives or household members who need help because of physical or mental illness, disability, substance misuse, or other conditions." The colorful and informative brochure is available in PDF format and can be printed directly from the site.
A valuable resource guide entitled Caregiver Resource Directory, 2nd edition, is also included on the Web site. The resource directory, packaged in a 3-ring binder, contains resources, facts, and advice about caring for a loved one. There is space for caregivers to organize additional resources and medical information regarding the patient. Among the many topics and valuable information are included tips for new caregivers, management of symptoms at home, handling of medical emergencies, goals of care, information on do-not-resuscitate orders, and hospice care. The directory is free of charge to patients, caregivers, healthcare professionals, and the public. You also have the option to download and print the entire directory from your computer via print-friendly PDF files.
NetofCare also has recently resumed its quarterly newsletter, which provides information and resources for family caregivers with grave illnesses. The Family Caregiver Program of Beth Israel Medical Center's Department of Pain Medicine and Palliative Care supports the newsletter. The site can be found at http://www.netofcare.org.
FDA Approval of a New Device for Infants
The recent FDA approval of a first-of-a-kind medical device, Olympic Cool-Cap, offers new hope to parents of infants born with moderate to severe hypoxic-ischemic encephalopathy (HIE). A potentially fatal injury to the brain of infants, HIE is caused by low levels of oxygen experienced during the birthing process. According to the FDA's news release, the annual incidence of moderate to severe HIE is approximately 5,000 to 9,000 infants. There has been no effective treatment to date. Support/symptomatic treatment is associated with a 20% mortality rate and a 25% rate of neurologic deficits leading to permanent disability.
Researchers believe there is a small window of opportunity after birth to prevent a lifetime of disability. Susan Adeniyi-Jones, a Jefferson neonatologist who has been testing the experimental cap, reported that slowing down the brain's metabolism and decreasing its energy needs allows the brain to funnel all its efforts toward healing and repair. The Olympic Cool-Cap works on this premise. The system consists of a cooling unit, a control unit, temperature probes, and a water-filled cap placed on the infant's head. It is designed to provide selective head cooling with mild below-normal body temperature cooling for term newborns and works by circulating water through the fitted cap to maintain the cap water at an operator-specified temperature. A radiant warmer maintains core body temperature based on rectal temperature values at slightly below-normal levels. The operation of the unit is manual and based on temperature values displayed on the monitor.
The approval of the unit was based on data from an international, multicenter, prospective, randomized study of 234 infants. The results of the study found the unit to be safe and effective. At 18 months of age, there were fewer deaths and fewer severe cases of neurodevelopmental disability in the cooled group than in the control group. Minor cardiac arrhythmias occurred more often in the cooled infants but were not unexpected because mild sinus bradycardia is known to be associated with hypothermia. All infants experiencing this event responded positively to appropriate therapy. The use of the cap also was linked to an increase in scalp edema, with all cases resolved before or after completion of the therapy.
As part of the conditions for FDA approval, the manufacturer will set up a patient registry to collect information on the device and track treatment outcomes. The company also is responsible for a training and certification program for all device operators.
Indications for use of the Cool-Cap include infants at 36 weeks gestational age or older with one of the following: Apgar score of 5 or lower 10 minutes after birth, continued need for resuscitation 10 minutes after birth, acidosis within 60 minutes of birth, or a base deficit of 16 mmol/L or more within 60 minutes of birth. Infants also must have moderate to severe encephalopathy consisting of an altered state of consciousness (lethargy, stupor, or coma) and at least one of the following: hypotonia, abnormal reflexes (including oculomotor or papillary abnormalities), absent or weak sucking response, and clinical seizures. The infant also must have an amplititude-integrated electroencephalogram/cerebral function monitor (aEEG/CFM) recording of at least 20 minutes that shows either moderately or severely abnormal aEEG scores. Use of the device is contraindicated for infants with an imperforate anus, evidence of head trauma, or skull fracture causing major intracranial hemorrhage, and for those weighing less than 1,800 g at birth.
The Cool-Cap is manufactured by Olympic Medical Corporation, a subsidiary of Natus Medical Incorporated, San Carolos, California. Natus plans to market the Cool-Cap system to level 3 neonatal intensive care units (NICUs) worldwide, with each center using 2 Cool-Cap devices.
SOURCE
U.S. Food and Drug Administration. FDA approves novel device that prevents or reduces brain damage in infants. Retrieved March 19, 2007 from http://www.fda.gov/bbs/topics/NEWS/2006/NEW01537.html
Doris J. Mosocco, RN, BSN, CHCE, COSC