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."
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.
CONCERTA® uses an advanced OROS® extended-release delivery system to deliver a controlled rate of medication throughout the day. Because of its unique OROS® system, CONCERTA® minimizes the ups and downs in blood levels experienced with stimulant medications taken several times a day.
CONCERTA® should not be taken by patients with: significant anxiety, tension, or agitation; allergies to methylphenidate or other ingredients in CONCERTA®; glaucoma, Tourette's syndrome, tics, or family history of Tourette's syndrome; current/recent use of monoamine oxidase (MAOIs). Abuse of methylphenidate may lead to dependence. CONCERTA® should not be taken by children under six years of age.
In clinical studies with patients using CONCERTA®, the most common side effects were headache, stomach pain, sleeplessness and decreased appetite. For more information about CONCERTA®, including full U.S. prescribing information, please visit www.concerta.net or call 1-888-440-7903.