, the Pharmaceuticals business of Covidien (NYSE: COV), today announced that it launched the 36 and 54 milligram (mg) dosage strengths of Methylphenidate HCl Extended-Release (ER) Tablets USP (CII), generic version of CONCERTA
. These two dosage strengths will be available in addition to the 27 mg dosage strength. The 27 mg dosage strength was made available in December 2012, when Mallinckrodt received approval from the U.S. Food and Drug Administration (FDA) to manufacture and market the tablets in 27, 36 and 54 mg dosage strengths.
Methylphenidate HCl ER Tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children 6 years of age and older, adolescents and adults up to the age of 65. The treatment is an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social). Mallinckrodt believes it holds a separate 180-day exclusivity period for each of the 36 and 54 mg dosage strengths, which began upon commercial launch of each respective dosage strength.
“The launch of these additional dosage strengths are important additions to our line of generic pharmaceutical products and we look forward to providing these affordable treatment options to patients coping with ADHD,” Mark Trudeau, President, Mallinckrodt, said.
Mallinckrodt is the largest U.S. supplier of opioid pain medications and the 12
largest generic pharmaceuticals manufacturer in the U.S., based on prescriptions. Covidien announced in December 2011 that it plans to spin off Mallinckrodt into a stand-alone company, a process expected to be completed in mid-2013.
IMPORTANT RISK INFORMATION FOR METHYLPHENIDATE HCl ER TABLETS
Methylphenidate HCl ER Tablets are indicated for the treatment of ADHD in children 6 years of age and older, adolescents and adults up to the age of 65.
IMPORTANT RISK INFORMATION
Methylphenidate HCl ER Tablets should be given cautiously to patients with a history of drug dependence or alcoholism. Chronic abusive use can lead to marked tolerance and psychological dependence with varying degrees of abnormal behavior.
Frank psychotic episodes can occur, especially with parenteral abuse. Careful supervision is required during withdrawal from abusive use since severe depression may occur. Withdrawal following chronic therapeutic use may unmask symptoms of the underlying disorder that may require follow-up.
Methylphenidate HCl ER Tablets are contraindicated in patients:
- With a known hypersensitivity to the product or its components;
- With marked anxiety, tension, or agitation;
- With glaucoma;
- With tics or a family history or diagnosis of Tourette’s syndrome; and
- Using or within 2 weeks of using a monoamine oxidase inhibitor
Serious adverse events, including sudden death, stroke and myocardial infarction, have been reported in patients taking usual doses.