FDA expands indication for ADDERALL XR (CII) confirming safety and efficacy in adolescents

Philadelphia, US July 22, 2005 Shire Pharmaceuticals Group plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) announced today that the US Food and Drug Administration (FDA) has approved ADDERALL XR (mixed salts of a single-entity amphetamine product) as a once-daily treatment for adolescents aged 13 to 17 with attention deficit hyperactivity disorder (ADHD). Since October 2001, ADDERALL XR has been approved in the U.S. for treatment in children aged 6 to 12 years and since August 2004 in adults 18 years and older. ADDERALL XR is currently the most commonly prescribed brand of ADHD medication in the United States.

"There has long been an unmet need for ADHD research and treatment among the adolescent population despite an increasing awareness of ADHD's potential impact on quality of life. Therefore, approval of an ADHD treatment for this underidentified age group is an important milestone," explained Dr. Timothy Wilens of Massachusetts General Hospital. "The symptoms of ADHD often continue past childhood into adolescence and adulthood, where they can have a significant impact on an individual's family, academic performance, and overall quality of life. Stimulant therapies are effective and generally well tolerated, and have been used medically in patients for more than 60 years."

ADHD affects approximately 3 to 7 percent of all school-age children, or approximately two million U.S. children, and 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 and/or hyperactivity-impulsivity that is more frequent and severe than is typically observed in individuals at a comparable age and maturity. ADHD can have a profound effect on a child's quality of life and can be serious enough to interfere beyond academics, leading to problems maintaining friendships, difficulties focusing on sports or other after-school activities, and challenge

Contact: Janice Miller, Vice President, Porter Novelli
Porter Novelli

Page: 1 2 3 4 5

Related medicine news :

1. Aflac expands decade-long partnership with AACR
2. $2.9M NIH grant expands successful parenting education program of Rush University
3. Wiley expands partnership with Skyscape
4. Medical device test center expands capabilities to help reduce potential interference
5. The $6 billion (hu)man is becoming reality, as bionics restores or expands humans abilities
6. Yale expands research using magnetic stimulation for schizophrenia
7. Mount Sinai expands cutting-edge molecular testing
8. Indians suffer poor health services while private sector expands for foreigners
9. Universitys HIV diagnostic test expands into European market
10. NIMH expands public health education effort
11. FDA expands Neulasta label

Post Your Comments:

(Date:2/21/2020)... Fla. (PRWEB) , ... February 21, 2020 , ... ... announced that it is now offering a 10 percent grand opening discount 0n ... 10 percent off all purchases," said Osmay Gonzalez, spokesperson for Baby Blendy LLC, ...
(Date:2/21/2020)... ... February 21, 2020 , ... ... from the American Society of Plastic Surgeons (ASPS). According to the ASPS, there ... a 2% increase over the previous year. The American Society of Plastic Surgeons ...
(Date:2/20/2020)... LAS VEGAS (PRWEB) , ... February 20, 2020 , ... ... 2020 in Las Vegas Nevada. Providers will learn how to perform injections for all ... practice is not easy to learn from online videos. The best opportunity is to ...
(Date:2/20/2020)... , ... February 20, 2020 , ... ... has a new release with next generation API integration functionality which enables ... VisitorsCoverage Inc. in 2017, TMQuotes was the first white label software-as-a-service ...
(Date:2/19/2020)... ... February 19, 2020 , ... ... and application deadline for its new Lifestyle Medicine Residency Curriculum (LMRC). The curriculum ... implementation into medical residency programs. Driven by resident involvement, the curriculum has ...
Breaking Medicine News(10 mins):
(Date:2/16/2020)... ... February 16, 2020 , ... In Partnership with the ... dental services at its Kennewick, WA office. , A limited number of appointments are ... schedule beforehand. For more information or to schedule an appointment, please call (509)-820-4302. , ...
(Date:2/15/2020)... Fla. (PRWEB) , ... February 14, 2020 , ... Clean ... and global sustainability, announced today that its full-service customer portal for hospitality partners has ... soap production by 52% in 2019. This has allowed Clean the World to produce ...
(Date:2/15/2020)... ANGELES (PRWEB) , ... February 14, 2020 , ... The ... and cooling pillow insert for a relaxing sleep experience—are excited to announce the launch ... planned, developed, and shipped four different types of pillows over the last four years. ...
Breaking Medicine Technology:
Cached News: