Shire Gets FDA Nod for 16-hr ADHD Drug

Jun 22, 2017

Boston Business Journal

The FDA has approved Shire's new long-acting ADHD drug, after a lengthy approval process.

The drug, Mydayis, has the same active ingredient as an extended-release version of Adderall but is designed to last for 16 hours, compared with Adderall XR's 12 hours.

Shire first sought approval for the med in 2006, but was rejected by the FDA. After conducting a total of 16 clinical trials involving more than 1,600 patients, Shire unveiled positive data in June 2016.

Shire predicts that Mydayis will be a $500 million product by 2020.

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