MONDAY, Aug. 27 (HealthDay) -- One of the biggest problems in managing attention deficit hyperactivity disorder (ADHD) in children is the regulation of the dosage of medicine.
Ritalin (methylphenidate) is the most-often prescribed drug to bring the hyperactivity under control. Now, Novartis, the company that makes Ritalin, has received tentative approval to move ahead in the marketing of a version of Ritalin that controls dosage much better.
The FDA has given Novartis and its partner, Celgene, what is termed an approvable letter for a refined formulation of Ritalin, which contains about half the dose now being used. The drug, dexmethylphenidate HCl(1), contains everything required for management of ADHD. This type of correspondence from the government usually represents the last step before a product receives final FDA approval.
This press release from Celgene gives the company's view as to why this new dosage regulation is so important.
ADHD interferes with a person's ability to control activity and
behavior, and to focus on particular tasks. The condition has been studied for more than 40 years, and a number of treatment options have become available. The use of Ritalin is widespread, and this site from Internet Mental Health explains its benefits and dangers.
