SHIRE GETS FDA APPROVABLE LETTER FOR DAYTRANA FOR ADHD.Shire plc has received an approvable letter from the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) for DAYTRANA (methylphenidate methylphenidate /meth·yl·phen·i·date/ (meth?il-fen´i-dat) a central stimulant, used in the form of the hydrochloride salt in the treatment of attention-deficit in children and narcolepsy. transdermal system), an investigational transdermal patch transdermal patch: see skin patch. formulation for methylphenidate designed for once-daily use to treat attention deficit hyperactivity disorder attention deficit hyperactivity disorder (ADHD), formerly called hyperkinesis or minimal brain dysfunction, a chronic, neurologically based syndrome characterized by any or all of three types of behavior: hyperactivity, distractibility, and impulsivity. (ADHD Attention-Deficit/Hyperactivity Disorder (ADHD) Definition Attention-deficit/hyperactivity disorder (ADHD) is a developmental disorder characterized by distractibility, hyperactivity, impulsive behaviors, and the inability to remain focused on tasks or ) in children aged 6 to 12 years. The approvable letter contains proposed labeling, as well as requests for data clarification, post-marketing surveillance, and post- marketing studies. Shire is now initiating dialogue with FDA to address these issues. "This approvable letter for DAYTRANA is positive news for Shire and our partner, Noven Pharmaceuticals," said Shire CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. Matthew Emmens. "We look forward to working with the FDA to agree on the final labeling for DAYTRANA. As the first and only non-oral medication for ADHD, DAYTRANA, if ultimately approved, will be a welcome new alternative to current therapies for patients diagnosed with ADHD." Shire and Noven Pharmaceuticals, Inc. submitted an amended New Drug Application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) for DAYTRANA to the FDA in June of this year. DAYTRANA is licensed globally to Shire by Noven. Shire hopes to reach final agreement with the FDA concerning DAYTRANA to allow for an on track launch during the first half of 2006. SHIRE PLC Shire's strategic goal is to become the leading specialty pharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its business on central nervous system, gastrointestinal, general products and human genetic therapies -- all being areas in which Shire has a commercial presence. The structure is sufficiently flexible to allow Shire to target new therapeutic areas to the extent opportunities arise through acquisitions. Shire believes that a carefully selected portfolio of products with strategically aligned and relatively small-scale sales forces will deliver strong results. Shire's strategy is to develop and market products for specialty physicians. Shire's in-licensing and merger and acquisition efforts are focused on products in niche markets with strong intellectual property protection either in the US or Europe. About DAYTRANA DAYTRANA is a Schedule II controlled substance controlled substance n. a drug which has been declared by federal or state law to be illegal for sale or use, but may be dispensed under a physician's prescription. . DAYTRANA was generally well tolerated in clinical studies. As with other products containing methylphenidate (the active ingredient in DAYTRANA), common side effects reported in children who received DAYTRANA were decreased appetite, insomnia, nausea, vomiting, weight loss, tic, and affect lability lability /la·bil·i·ty/ (lah-bil´i-te) 1. the quality of being labile. 2. in psychiatry, emotional instability. lability the quality of being labile. (mood swings). DAYTRANA should not be used by children with allergies to methylphenidate or other ingredients in DAYTRANA. The patch should be applied daily to clean, dry skin, which is free of any cuts or irritation. Avoid applying external heat to the patch. Skin irritation may occur. Methylphenidate should not be taken by children with significant anxiety, tension, or agitation; glaucoma; tics; Tourette's syndrome, or family history of Tourette's syndrome; or current/recent use of MAO inhibitors (a type of antidepressant antidepressant, any of a wide range of drugs used to treat psychic depression. They are given to elevate mood, counter suicidal thoughts, and increase the effectiveness of psychotherapy. ). Abuse of methylphenidate may lead to dependence. Tell your healthcare professional if your child has had problems with alcohol or drugs or has had depression, abnormal thoughts/behaviors, visual disturbances, seizures, high blood pressure, or heart conditions. About ADHD ADHD affects approximately 7.8 percent of all school-age children, more than 4 million in the United States. ADHD is considered the most commonly diagnosed psychiatric disorder in children and adolescents. ADHD is a neurological brain disorder that manifests as a persistent pattern of inattention in·at·ten·tion n. Lack of attention, notice, or regard. Noun 1. inattention - lack of attention basic cognitive process - cognitive processes involved in obtaining and storing knowledge and/or hyperactivity-impulsivity that is more frequent and severe than is typically observed in individuals at a comparable age and maturity. If untreated, ADHD can acutely affect a child's life, leading to problems with family members, friends, sports, after-school activities and academics. For more information, call 484/595-8252 or visit http://www.shire.com. |
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