Healthcare Industry News: S.A.
News Release - August 31, 2023
Mallinckrodt Receives U.S. FDA Approval for Lisdexamfetamine Dimesylate Capsules and Launches Product Used to Treat Attention-Deficit/Hyperactivity Disorder (ADHD)
DUBLIN, Aug. 31, 2023 -- (Healthcare Sales & Marketing Network) -- Mallinckrodt plc (OTCMKTS: MNKTQ), a global specialty pharmaceutical company, today announced that its Specialty Generics segment, operating as SpecGx LLC, received approval on August 25, 2023 from the United S.A.es Food and Drug Administration (FDA) for itS.A.breviated New Drug Application for Lisdexamfetamine Dimesylate Capsules 10mg, 20mg, 30mg, 40mg, 50mg, 60mg, and 70mg. The FDA determined SpecGx LLC's product was bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Vyvanse® Capsules of Takeda Pharmaceuticals U.S.A., Inc. (Takeda), in all seven of the RLD'S.A.proved strengths.Lisdexamfetamine Dimesylate CapsuleS.A.e a federally controlled subS.A.ce (CII) used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) and other indicationS.A.d currently are on the FDA's drug shortage list. Global net sales of Lisdexamfetamine Dimesylate exceeded $3.0 billion in Takeda's fiS.A. year ended March 31, 2023.
Upon receiving approval, which came the day following the expiration of the RLD's pediatric exclusivity, Mallinckrodt began immediate commercialization of the product. SpecGx LLC's generic version is manufactured at its plant in Hobart, New York utilizing active pharmaceutical ingredient manufactured at its plant in St. Louis, Missouri.
"Lisdexamfetamine Dimesylate is included among the ADHD medications currently on the FDA's drug shortage list, so we are very pleased to be able to launch this product at this time to help addresS.A.critical need in the market," said Stephen Welch, Executive Vice President and Head of Specialty Generics. "We will be working closely with the Drug Enforcement Administration (DEA) to request and secure additional quota to increase our production following thiS.A.proval because we underS.A.d the vital importance of patient access to affordable, high-quality generic ADHD medicines."
ABOUT MALLINCKRODT
Mallinckrodt iS.A.global business consisting of multiple wholly owned subsidiaries that develop, manufacture, market and distribute specialty pharmaceutical productS.A.d therapies. The Company's Specialty Brands reportable segment'S.A.eas of focus include autoimmune and rare diS.A.es in specialty areas like neurology, rheumatology, hepatology, nephrology, pulmonology, ophthalmology and oncology; immunotherapy and neonatal respiratory critical care therapies; analgesics; cultured skin substituteS.A.d gastrointestinal products. Its Specialty Generics reportable segment includes specialty generic drugS.A.d active pharmaceutical ingredients. To learn more about Mallinckrodt, visit www.mallinckrodt.com.
Mallinckrodt uses its website aS.A.channel of distribution of important company information, such as press releases, investor presentationS.A.d 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 U.S. SecuritieS.A.d Exchange Commission (SEC) disclosing the same information. Therefore, investors should look to the Investor Relations page of the website for important and time-critical information. Visitors to the website can also register to receive automatic e-mail and other notificationS.A.erting them when new information is made available on the Investor Relations page of the website.
CAUTIONARY S.A.EMENTS RELATED TO FORWARD-LOOKING S.A.EMENTS
This release contains forward-looking S.A.ements, including with regard to the Mallinckrodt's launch of Lisdexamfetamine Dimesylate Capules used to treat ADHD. The S.A.ementS.A.e based on assumptionS.A.out many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking S.A.ements: the impact of Mallinckrodt's pending Chapter 11 cases; issues with product quality, manufacturing or supply, or patient safety issues; Mallinckrodt'S.A.ility to work with the DEA to request and secure additional quota to increase its production of Lisdexamfetamine Dimesylate Capules following FDA approval; satiS.A.tion of, and compliance with, regulatory and other requirements; actions of regulatory bodieS.A.d other governmental authorities; changes in lawS.A.d 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 SEC, all of which are available on its website. The forward-looking S.A.ements made herein speak only as of the date hereof and Mallinckrodt does not assume any obligation to update or revise any forward-looking S.A.ement, whether aS.A.result of new information, future eventS.A.d developments or otherwise, except as required by law.
Mallinckrodt, the "M" brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company.
Source: Mallinckrodt
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