News Release

Mallinckrodt Responds to FDA Reclassification Of Methylphenidate ER

Mallinckrodt plc (NYSE: MNK) confirmed that on November 17, 2014 it filed a lawsuit against the U.S. Food and Drug Administration (FDA) in the United States District Court for the District of Maryland. The company has taken this action in response to what it believes is the Agency’s inappropriate and unlawful reclassification of Mallinckrodt’s methylphenidate hydrochloride extended release (ER), USP (CII) medicines in the Orange Book: Approved Drug Products with Therapeutic Equivalence (Orange Book) on November 13, 2014.

In its complaint, Mallinckrodt requests:

  • issuance of an injunction to (a) set aside the FDA’s November 13, 2014 action, which reclassified Mallinckrodt’s methylphenidate ER medicines from AB (freely substitutable at the pharmacy level) to BX (presumed to be therapeutically inequivalent) in the Orange Book; and (b) prohibit the FDA from reclassifying Mallinckrodt’s methylphenidate ER medicines in the future without following applicable legal requirements.
  • issuance of a declaratory judgment that the FDA’s action reclassifying Mallinckrodt’s methylphenidate ER medicines in the Orange Book is unlawful.

On November 17, 2014, Mallinckrodt filed a motion with the same court requesting an expedited hearing to issue a temporary restraining order (TRO) directing the FDA to reinstate the Orange Book AB rating for the company’s methylphenidate ER medicines on a temporary basis.

“Mallinckrodt stands behind the safety and efficacy of our medications, and in its own release, the FDA affirmed that it had ‘not identified any serious safety concerns’ with Mallinckrodt’s methylphenidate ER medicines,” said Peter Edwards, Senior Vice President and General Counsel of Mallinckrodt plc. “We initiated legal action with the best interests of our patients in mind, and did so only after repeated and unsuccessful attempts to engage in meaningful discussion with the FDA about this reclassification. The FDA’s unilateral decision could result in patient anxiety and uncertainty, potential disruption to an effective ADHD therapy, possible market shortages, and unfavorable changes in the economics for ADHD patients and providers.”

Mallinckrodt’s methylphenidate ER medicines have consistently met all quality specifications and regulatory requirements originally defined by the FDA, and in the 21 months since launch more than 88 million doses of Mallinckrodt’s methylphenidate ER medicines have been prescribed. In that time, and across all of those patient exposures, the company has received only 68 confirmed adverse event reports related to a lack of efficacy when the patient switched from the reference listed drug Concerta® to the company’s methylphenidate ER medicines.


November 19, 2014

Source, IMS Health