The Ingredients: Triamcinolone Acetonide
Dosage Form and Administration: Ointment; Topical
Drug Trade Name: Triamcinolone Acetonide
Firm: Taro
Strength: 0.03%
New Drug Application Type: A
The Drug Application Number: 40374
Medicine Product Number: 1
Approval Date: 6/5/2001
Reference Listed Drug: No
Type: RX
Applicant Full Name: Taro Pharmaceuticals Usa Inc
Local Number: 35475

Cognitive Behavioral Therapy

Doctors developed cognitive behavioral therapy as a method of preventing relapse when treating a patient with problem drinking. Later cognitive doctors adapted behavioral therapies to help individuals addicted to cocaine. Cognitive behavioral strategies stem from the theory that learning processes play a critical role in the development of maladaptive behavioral patterns. Individuals learn to identify and correct problematic behaviors by applying a range of different skills to stop drug abuse and to address other problems that often exist with it. Therapies for treating alcohol, marijuana, cocaine, methamphetamine and nicotine exist. Cognitive behavioral therapy generally consists of a collection of strategies that aim to enhance self control. Specific techniques include: exploring the positive and negative consequences of continued use, monitoring oneself to recognize drug cravings early on and to identify risky situations for use and developing strategies for coping with and avoiding risky situations associated with the desire to use. A central element of cognitive behavioral therapy is anticipating problems and helping patients develop effective coping strategies. Research indicates that the skills individuals learn through cognitive behavioral approaches remain in use after the completion of treatment. In several studies, most people who choose a cognitive behavioral approach to recovery showed progress throughout the following year. Current research focuses on how to produce effects that are even more powerful by combining cognitive behavioral therapy with medications for drug abuse and with other types of behavioral therapies. Researchers are also evaluating how best to train treatment providers to deliver cognitive behavioral therapy.

Medical Device

A medical device is a product used for medical purposes in patients, in diagnosis, therapy or surgery. Medicinal products achieve their principal action by pharmacological, metabolic or immunological, medical devices act by other means like physical, mechanical, physio-chemical or chemical means. Medical devices are a part of medical technology. Medical devices include a wide range of products varying in complexity and application. The Food and Drug Administration recognizes three classes of medical devices based on the level of control necessary to assure the safety and effectiveness of the devices. Class I devices are subject to the least regulatory control. "General Controls" apply to all Class I, II and III devices. General controls include provisions that relate to adulteration; misbranding; device registration and listing; pre-market notification; banned devices; notification, including repair, replacement, or refund; records and reports; restricted devices; and good manufacturing practices. Class I devices are not intended for use in supporting or sustaining life or to be of substantial importance in preventing impairment to human health, and they may not present a potential unreasonable risk of illness or injury. Most Class I devices are exempt from the pre-market notification and/or good manufacturing practices regulation. Class II devices are those for which general controls alone are insufficient to assure safety and effectiveness, and existing rules provide such assurances. In addition to complying with general controls, Class II devices are also subject to special controls. A few Class II devices are exempt from pre-market notification [10]. Special controls may include particular labeling requirements, mandatory performance standards and post-market surveillance. The FDA holds Class II medical devices to a higher level of assurance than Class I devices, as Class II devices must perform as indicated without causing injury or harm to patient or user. Examples of Class II devices include powered wheelchairs, infusion pumps and surgical drapes. A Class III device is one for which insufficient information exists to assure safety and effectiveness solely through the general or special controls sufficient for Class I or Class II devices. Such a device needs pre-market approval, a scientific review to ensure the safety and effectiveness of the device, and is subject to all the general controls of Class I devices. The FDA classifies Class III devices as those that support or sustain human life and are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury. Examples of Class III devices (which currently require a pre-market notification) include implantable pacemaker pulse generators and endosseous implants.