BIOTECHNOLOGY

Covidien’s Mallinckrodt lands FDA approval for ADHD drug

COURTESY COVIDIEN PLC
THE PHARMACEUTICAL ARM of med-tech company Covidien Plc has received FDA approval to manufacture and market a generic version of its Concerta drug for the treatment of ADHD.
Posted 12/31/12

MANSFIELD – Mallinckrodt, the pharmaceuticals business of biotechnology giant Covidien PLC, has received approval from the U.S. Food and Drug Administration to manufacture and market a generic version of its Concerta tablets for the treatment of attention deficit hyperactivity disorder, the company announced Monday.

Mallinckrodt holds six-month exclusivity on 27-, 36- and 54-milligram dosage strengths of the Methylphenidate HCl ER tablets for ADHD treatment.

The 180-day exclusivity begins on the commercial launch of each respective dosage strength. The company’s current plan is to have the 36mg and 54mg dosage strengths commercial available during the first three months of 2013.

Mallinckrodt plans to submit a supplement to its approved abbreviated new drug application for the 18mg dosage during the first calendar quarter of the new year.

“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,” Mark Trudeau, Mallinckrodt president, said in prepared remarks. “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 supplier of opioid pain medications in the United States and is among the top 10 generic pharmaceuticals manufacturers in the United States based on prescriptions.

In December 2011 Covidien announced that it plans to spin off Mallinckrodt into a stand-alone company, a process expected to be completed in mid-2013.

No comments on this story | Add your comment
Please log in or register to add your comment
Calendar
PBN Hosted
Events

Only a few seats remain for PBN's Manufacturing Awards Dinner and Ceremony, Thursday, April 24th, at the Bryant University Bello Center. Don't hesitate. Register today!
  • Business Women
    Accomplished. Confident. Wicked Smart. Nominate women you know who deserve speci ...
  • 40 Under Forty
    It's the 10th Anniversary of 40 Under Forty, and PBN is planning a special event ...
  • Healthiest Employers
    Enrollment now open for the 2014 Healthiest Employers Program. Please take a mom ...
Advertisement
Purchase Data
Book of Lists
Lists
Book of Lists cover
PBN's annual Book of Lists has been an essential resource for the local business community for almost 30 years. The Book of Lists features a wealth of company rankings from a variety of fields and industries, including banking, health care, real estate, law, hospitality, education, not-for-profits, technology and many more.
Data icons
Data can be purchased as single lists, in either Excel or PDF format; the entire database of the published book, in Excel format; or a printed copy of the Book of Lists.
  • Purchase an e-File of a single list
  •  
  • Purchase an e-File of the entire Book of Lists database
  •  
  • Purchase a printed copy of the Book of Lists
  •  
    National
    Local
    Latest News