Apotex has received a Drug Shortage Assistance Award from the 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.
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