Apotex Receives FDA’s Drug Shortage Assistance Award
Apr 19, 2023Recognized for efforts in resolving shortage of varenicline tablets
Toronto, Ontario (April 19, 2023) - Apotex Inc. is pleased to announce that it has received a Drug Shortage Assistance Award from the U.S. Food and Drug Administration (FDA) in recognition of the company’s substantial efforts to resolve a shortage of varenicline tablets.
When the US market experienced a shortage of 0.5 mg and 1 mg varenicline tablets, and in order to reduce the impact to patients from an ongoing recall, the FDA temporarily exercised regulatory flexibility and discretion with respect to Apotex’s importation of Health-Canada approved Apo-Varenicline tablets in the U.S. The award also recognizes the submission and ultimate approval of an abbreviated new drug application (ANDA) for varenicline tablets in the U.S. market.
“We’re proud to receive this important award from the FDA, and to be recognized for our commitment to public health” said Allan Oberman, President and Chief Executive Officer, Apotex. “Our flexible supply chain and North American manufacturing model helped ensure an uninterrupted supply of medicines and demonstrates our focus on increasing access to affordable, high quality products.”
This award recognizes the efforts of drug companies and manufacturers who have worked in cooperation with FDA, and have implemented strategies to help provide a steady supply of medically necessary drugs at a time when critical drug shortages pose a substantial public health threat – delaying, and in some cases even denying, critically needed care for patients. Working with drug companies and manufacturers like Apotex, the FDA helped prevent 317 drug shortages in 2021.
About Apotex Inc.
Apotex is a proudly Canadian-based, global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs nearly 8,000 people worldwide in manufacturing, R&D, and commercial operations. It exports to more than 100 countries and territories and operates in more than 45 countries, with a significant presence in Canada, the United States, Mexico, and India. For more information, visit www.apotex.com.
-30-
All media enquiries :
Jordan Berman
Vice-President, Global Corporate Affairs
Apotex Inc.
jberman@apotex.com
Mobile: 647-272-2287
Media inquries
Have a question for our media team? Fill out our inquiries form, and we’ll get back to you as soon as possible.
Latest news
-
May 25, 2025
Apotex launches nilotinib capsules, the first generic version of Tasigna®¹ in the United States, with 180 days of exclusivity
Nilotinib is a kinase inhibitor indicated to treat certain types of leukemia, including newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia ("Ph+ CML") in chronic phase in adults and children aged 1 year and older. It is also indicated for adults and pediatric patients with chronic or accelerated phase Ph+ CML with resistance or intolerance to prior therapy, demonstrating higher efficacy compared with other available treatments.
-
May 20, 2025
Apotex publishes 2024 Sustainability Report, highlighting progress and achievements in environmentally sustainable manufacturing, responsible business practices, and social impact
Apotex's 2024 Sustainability Report underscores our commitment to advancing health and unlocking new possibilities through partnerships, while championing sustainability and responsible business practices. "As we continue to execute our Journey of Health growth strategy, our focus on sustainability ensures that we are meeting the needs of patients, physicians, and pharmacists, and contributing positively to the environment and society. This report reflects our dedication to these values, and to transparency, accountability, and long-term value creation," said Allan Oberman, President & CEO, Apotex.
-
May 9, 2025
Apotex introduces IVRA™ (Melphalan) hydrochloride injection: First ready to dilute liquid formulation of Melphalan injection approved via 505(b)(2) NDA in the United States
Weston, Florida (May 09, 2025) – Apotex Corp. today launched IVRA™ (Melphalan) hydrochloride injection 90mg/ml multidose vial ("IVRA"), first ready-to-dilute liquid formulation of Melphalan injection approved via 505(b)(2) NDA in the United States.