Content about Lisdexamfetamine

September 12, 2012

Drug maker Shire is seeking Food and Drug Administration approval for a new usage for a drug used to treat attention deficit hyperactivity disorder, the company said Wednesday.

PHILADELPHIA — Drug maker Shire is seeking Food and Drug Administration approval for a new usage for a drug used to treat attention deficit hyperactivity disorder, the company said Wednesday.

Shire announced that the FDA had accepted its regulatory approval application for Vyvanse (lisdexamfetamine dimesylate) capsules for maintenance treatment of ADHD in patients ages 6 to 17 years. There currently are no stimulants approved for maintenance treatment of the condition in that age group, Shire said, and the FDA said it would complete its review by April 2013.

March 7, 2012

Drug maker Shire will conduct two post-marketing trials to compare its treatment for attention deficit hyperactivity disorder with a competing drug, the company said Tuesday.

PHILADELPHIA — Drug maker Shire will conduct two post-marketing trials to compare its treatment for attention deficit hyperactivity disorder with a competing drug, the company said Tuesday.

Shire announced that it would start two phase-4 trials comparing its drug, Vyvanse (lisdexamfetamine dimesylate), with Alza's Concerta (methylphenidate hydrochloride).

February 7, 2012

The Food and Drug Administration has approved a drug made by Shire for attention deficit hyperactivity disorder, the company said Tuesday.

PHILADELPHIA — The Food and Drug Administration has approved a drug made by Shire for attention deficit hyperactivity disorder, the company said Tuesday.

Shire announced the FDA approval of Vyvanse (lisdexamfetamine dimesylate) capsules as a maintenance treatment for adults with ADHD. The drug already was approved for use in children and was approved for treating ADHD in adults in 2008.

The company said the approval was based on a clinical trial that showed more ADHD patients controlling their symptoms with Vyvanse than with placebo.

July 8, 2011

Watson Pharmaceuticals has filed with the Food and Drug Administration for regulatory approval for a drug to treat attention deficit hyperactivity disorder, the company said Thursday.

PARSIPPANY, N.J. — Watson Pharmaceuticals has filed with the Food and Drug Administration for regulatory approval for a drug to treat attention deficit hyperactivity disorder, the company said Thursday.

Watson said it submitted its application for lisdexamfetamine dimesylate capsules, a generic version of Shire’s Vyvanse.

July 5, 2011

Shire has filed patent infringement suits against two generic drug makers relating to its attention deficit hyperactivity disorder treatment.

DUBLIN — Shire has filed patent infringement suits against two generic drug makers relating to its attention deficit hyperactivity disorder treatment.

Shire said it has filed lawsuits in the U.S. District Court for the District of New Jersey against Amneal Pharmaceuticals and Sandoz. Amneal and Sandoz recently filed abbreviated new drug applications with the Food and Drug Administration to market generic Vyvanse (lisdexamfetamine), an ADHD drug.

May 20, 2011

Sandoz is looking to market a generic version of a Shire drug for treating attention deficit hyperactivity disorder.

DUBLIN — Sandoz is looking to market a generic version of a Shire drug for treating attention deficit hyperactivity disorder.

April 6, 2011

British drug maker Shire has filed suit against Watson Pharmaceuticals and subsidiaries, alleging patent infringement in a case concerning a drug used to treat attention deficit hyperactivity disorder.

DUBLIN — British drug maker Shire has filed suit against Watson Pharmaceuticals and subsidiaries, alleging patent infringement in a case concerning a drug used to treat attention deficit hyperactivity disorder.

Shire announced Wednesday that it had filed the suit in the U.S. District Court for the Southern District of New York against Watson and several subsidiaries over their attempt to market a generic version of Adderall XR (amphetamine, dextroamphetamine mixed salts) and breach of contract.

November 14, 2010

The Food and Drug Administration has approved an attention deficit hyperactivity disorder drug for use...

PHILADELPHIA — The Food and Drug Administration has approved an attention deficit hyperactivity disorder drug for use in adolescents.

British drug maker Shire announced Monday the approval of Vyvanse (lisdexamfetamine dimesylate) capsules for patients aged 13 to 17. The drug was already approved for children ages 6 years to 12 years and adults.

May 19, 2010

British drug maker Shire will present data on two attention deficit hyperactivity disorder treatments in...

March 3, 2010

The U.S. District Court for the District of Columbia has upheld a decision by the...