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Approvable Letter Issued for Methylphenidate for Treatment of Attention Deficit Hyperactivity Disorder
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.
Source: McNeil Consumer & Specialty Pharmaceuticals