McNeil Consumer & Specialty Pharmaceuticals has received an approvable letter from the
U.S. Food and Drug Administration (FDA) for the use of
CONCERTA® (methylphenidate HCl) CII Extended-release Tablets in adolescents with Attention Deficit/Hyperactivity Disorder (ADHD) and to expand labeling to include a 72 mg dosing regimen.
FDA approval is contingent upon agreement of final labeling and submission of additional analyses from existing studies.
"We are delighted to reach this important milestone for CONCERTA® and are working closely with FDA to bring this new dosage option to patients, families and health care professionals as quickly as possible," said Minnie V. Baylor-Henry, R.Ph., J.D., vice president, Medical & Regulatory Affairs, McNeil Consumer & Specialty Pharmaceuticals.
CONCERTA® tablets are currently available in 18 mg, 27 mg, 36 mg and 54 mg strengths. "There will be no 72 mg tablet," explained Baylor-Henry. "While physicians will determine how the medication should best be taken by patients for whom it is prescribed, we believe CONCERTA® 72 mg will most often be taken as a once-a-day morning dose of two CONCERTA® 36 mg tablets."
About CONCERTA®
CONCERTA® (methylphenidate HCl) CII is a once-daily extended-release formulation of methylphenidate approved to treat ADHD. The efficacy of CONCERTA® has been demonstrated in studies conducted in children and adolescents. Only a doctor can determine if medication is the right treatment for individuals with ADHD.