, the Pharmaceuticals business of Covidien (NYSE: COV), today announced that it has received approval from the U.S. Food and Drug Administration (FDA) to manufacture and market a generic version of CONCERTA
(methylphenidate HCl) Extended-Release (ER) Tablets USP (CII) in 27, 36 and 54 mg dosage strengths. The company will launch Methylphenidate HCl ER Tablets in the 27 mg dosage strength immediately.
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 as 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 27, 36 and 54 mg dosage strengths, which begins upon commercial launch of each respective dosage strength. Mallinckrodt’s current plan is to have the 36 mg and 54 mg dosage strengths commercially available in the first calendar quarter of 2013. Mallinckrodt plans to submit a supplement to its approved abbreviated new drug application for the 18 mg dosage strength in the first calendar quarter of 2013.
“This approval represents an important addition to our line of generic pharmaceutical products, and we look forward to providing an affordable treatment option to patients coping with ADHD,” said Mark Trudeau, President, Mallinckrodt. “We are pleased the FDA found that our long-acting technology delivers a dose which is therapeutically equivalent to what is currently on the market."
Mallinckrodt is the largest U.S. supplier of opioid pain medications and among the top 10 generic pharmaceuticals manufacturers 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.