The FDA determined
Lisdexamfetamine Dimesylate Capsules are a federally controlled substance (CII) used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) and other indications and currently are on the
Upon receiving approval, which came the day following the expiration of the RLD's pediatric exclusivity, Mallinckrodt began immediate commercialization of the product.
'Lisdexamfetamine Dimesylate is included among the ADHD medications currently on the
ABOUT MALLINCKRODT
Mallinckrodt is a global business consisting of multiple wholly owned subsidiaries that develop, manufacture, market and distribute specialty pharmaceutical products and therapies. The Company's Specialty Brands reportable segment's areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, hepatology, nephrology, pulmonology, ophthalmology and oncology; immunotherapy and neonatal respiratory critical care therapies; analgesics; cultured skin substitutes and gastrointestinal products. Its Specialty Generics reportable segment includes specialty generic drugs and active pharmaceutical ingredients.
Mallinckrodt uses its website as a channel of distribution of important company information, such as press releases, investor presentations and other financial information. It also uses its website to expedite public access to time-critical information regarding the Company in advance of or in lieu of distributing a press release or a filing with the
CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTS
This release contains forward-looking statements, including with regard to the Mallinckrodt's launch of Lisdexamfetamine Dimesylate Capules used to treat ADHD. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: the impact of Mallinckrodt's pending Chapter 11 cases; issues with product quality, manufacturing or supply, or patient safety issues; Mallinckrodt's ability to work with the DEA to request and secure additional quota to increase its production of Lisdexamfetamine Dimesylate Capules following FDA approval; satisfaction of, and compliance with, regulatory and other requirements; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; competition; pricing pressure on Mallinckrodt's products and other risks identified and described in more detail in the 'Risk Factors' section of Mallinckrodt's most recent Annual Report on Form 10-K and other filings with the
Contact:
Tel: 314-654-3638
Email: daniel.speciale@mnk.com
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