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(August 13, 2004) -- US regulators have given approval for a treatment for an adult version of Attention Deficit Hyperactivity Disorder, Shire Pharmaceuticals says.
It is to begin promoting the once-a-day adult version of the drug in the US immediately, the group said.
The US Food and Drug Administration in November 2001 approved Adderall XR for the treatment of ADHD in children.
Net sales of Adderall XR in the six months to the end of June 2004 were £154m, up 30% year-on-year, Shire said.
"Although we have not been able to promote adult usage, many physicians have been prescribing Adderall XR for adults 'off label' for some time," CEO Matthew Emmens said.
"Adults represent 15% - 20% of the current Adderall XR total prescriptions. We can now support the expansion of this adult market segment," he said.
Shire also said the FDA wanted additional clinical data before giving approval for new 40mg, 50mg and 60mg dose strengths of Adderall XR.
The drug is a once-daily extended release, single-entity amphetamine product currently available in doses from 5mg to 30mg.
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