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May 30, 2017
The U.S. Food and Drug Administration today approved the first generic versions of Strattera (atomoxetine) to treat attention-deficit/hyperactivity disorder (ADHD) in pediatric and adult patients.
Apotex Inc., Teva Pharmaceuticals USA Inc., Aurobindo Pharma Limited and Glenmark Pharmaceuticals Limited today gained approval to market atomoxetine in multiple strengths.
“Today’s approvals mark an important step forward in bringing consumers additional treatments that have met the FDA’s rigorous standards,” said Kathleen Uhl, M.D., director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research. “Quickly bringing generics to market so patients have more options to treat their conditions is a top priority for the FDA.”
Generic prescription drugs approved by the FDA have the same high quality and strength as brand-name drugs. Generic prescription drug manufacturing and packaging sites must pass the same quality standards as those of brand-name drugs.
ADHD is marked by an ongoing pattern of inattention and/or hyperactivity-impulsivity that interferes with functioning or development.
In the clinical trials for atomoxetine in children and adolescents, the most common side effects reported were upset stomach, decreased appetite, nausea or vomiting, dizziness, tiredness, and mood swings. In the clinical trials in adults, the most common side effects reported were constipation, dry mouth, nausea, decreased appetite, dizziness, sexual side effects, and problems passing urine.
Atomoxetine must be dispensed with a patient Medication Guide that describes the drug’s uses and warnings. This medication has a boxed warning for the increased risk of suicidal ideation in children and adolescents. Patients taking this medication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes. Other important warnings include the risk of severe liver damage and potential for serious cardiovascular events.
Yet more good news for Shire has come with the US Food and Drug Administration approving its attention-deficit hyperactivity disorder blockbuster Vyvanse for binge-eating disorder, the first medicine approved by the agency to treat this condition.
The agency has expanded approval on Vyvanse (lisdexamfetamine dimesylate) for adults with BED based on two Phase III studies which showed that it was statistically superior to placebo in terms of number of binge days per week. BED affects around 2.8 million US adults and is more prevalent than anorexia nervosa and bulimia nervosa combined.
Originally discovered and developed by New River Pharmaceuticals, the company entered into a collaborative agreement with Shire Pharmaceuticals in 2005 for global commercialization of the drug candidate. After Shire’s acquisition of New River Pharmaceuticals in April 2007, lisdexamfetamine entered the product portfolio of Shire.
In 2009, the compound was licensed to GlaxoSmithKline by Shire in the U.S. for comarketing for the treatment of attention deficit/hyperactivity disorder (ADHD). In 2010, this license agreement was terminated. The product was licensed to Shionogi by Shire in Japan for co-development, co-commercialization, and co-promotion for the treatment of attention deficit/hyperactivity disorder (ADHD).
Lisdexamfetamine (NRP-104), a conditionally bioreversible derivative of amphetamine, was launched in the U.S. in 2007 for the treatment of attention deficit hyperactivity disorder (ADHD) in children aged 6-12 years old. In 2008, the product was approved for use in adults, and in 2009 it was approved in Canada, followed by commercialization in 2010. In 2010, FDA approval was obtained for use in treatment of ADHD in adolescents aged 13 to 17 years and launch took place the same year. Approval for the treatment of adolescents was assigned in Canada in 2011.
In 2012, Shire filed a regulatory application in Europe via the decentralized procedure with the U.K. acting as the reference member state, for the treatment of ADHD in children and adolescent patients aged 6 to 17 years. This indication was approved in 2013. Also, in 2012 FDA approval was granted for the maintenance treatment for adults with ADHD. U.K., DK and SE are awaiting approval for the same indication in a decentralized procedure initiated in 2014 with the U.K. acting as the reference member state. In 2014, the company filed with priority review a supplemental New Drug Application (sNDA) in the U.S. for the treatment binge eating in adults.
Binge eating,,,,,, express their stress as temper tantrums or by indulging in compulsive eating spree
In terms of clinical development, phase III clinical trials are ongoing at Shionogi in Japan for the treatment of ADHD.. The National Institute on Drug Abuse (NIDA) is evaluating the compound in early clinical studies for the treatment of methamphetamine dependence. Phase III trials were underway as an adjunctive treatment of major depressive disorder; however, they were discontinued due to lack of efficacy. A phase II clinical trial for the treatment of excessive daytime sleepiness (EDS) has been completed. Shire had been evaluating the compound in clinical studies for the treatment of chronic fatigue syndrome.
In 2013, Shire cancelled its phase III program evaluating the product for the negative symptoms of schizophrenia based on a review and prioritization of the company’s development portfolio.
Patent and Exclusivity Search Results from query on Appl No 021977 Product 003 in the OB_Rx list.
|Appl No||Prod No||Patent No||Patent
|N021977||003||7105486||Jun 29, 2023||U – 727|
|N021977||003||7223735||Jun 29, 2023||Y|
|N021977||003||7655630||Feb 24, 2023||Y|
|N021977||003||7659253||Feb 24, 2023||Y||Y||U – 727|
|N021977||003||7659254||Feb 24, 2023||U – 1034|
|N021977||003||7662787||Feb 24, 2023||Y|
|N021977||003||7662788||Feb 24, 2023||U – 727|
|N021977||003||7671030||Feb 24, 2023||Y||U – 727|
|N021977||003||7671031||Feb 28, 2023||U – 727|
|N021977||003||7674774||Mar 18, 2023||Y||U – 842|
|N021977||003||7678770||Mar 25, 2023||U – 842|
|N021977||003||7678771||Mar 25, 2023||Y||U – 842|
|N021977||003||7687466||Feb 24, 2023||Y|
|N021977||003||7687467||Apr 8, 2023||Y||U – 842|
|N021977||003||7700561||Jun 29, 2023||Y|
|N021977||003||7713936||Feb 24, 2023||U – 727|
|N021977||003||7718619||Feb 24, 2023||Y||U – 842|
|N021977||003||7723305||Feb 24, 2023||Y||U – 842|
|Appl No||Prod No||Exclusivity Code||Exclusivity Expiration|
|N021977||003||I – 645||Jan 31, 2015|