A U.S. District Court has given exclusivity rights to Shire for its ADHD drug Vyvanse. The decision comes in the wake of a lawsuit filed by Actavis Elizabeth which sought permission to begin selling a generic version of the drug.

"The FDA gave the ADHD drug Vyvanse (lisdexamfetamine disemsylate) five years of market exclusivity on account of its being a new chemical entity in 2007.

For that reason, it refused to file an approval application for a generic version of the drug submitted by Actavis Elizabeth. Actavis sued the FDA in February 2009 & to challenge the decision." [Source: Alaric DeArment, Drug Store News, March 4]

Shire's exclusivity will expire in February 2012. As a result, applications for generic versions can't be filed until then.

Like other popular ADHD medications (such as Ritalin and Adderall), Vyvanse is a stimulant that is used to control symptoms in children and adults.

Labels: medications, vyvanse

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Drug manufacturer Shire has released the results of a study aimed at tracking the effectiveness of its drug Vyvanse on adolescents diagnosed with ADHD. Currently, the drug is only approved for treatment of children and adults.

"In this study, Vyvanse improved ADHD symptoms of inattention, hyperactivity and impulsivity in adolescents compared to a placebo," said Ann C. Childress, MD, president of the Center for Psychiatry and Behavioral Medicine, Inc. in Las Vega, Nevada and lead investigator for this study. "These results are important as we look for additional ways to effectively manage ADHD symptoms in adolescent patients." [Source: Shire press release]

As a result of the study, Shire plc has submitted a supplemental New Drug Application (sNDA) to the FDA, requesting that Vyvanse be approved for treatment of ADHD in teenagers. There’s no indication as to when, or if, the application will be approved.

 

Labels: medications, vyvanse, drugs

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