The Food and Drug Administration (FDA) is taking final official action withdrawing the approval of two new drug applications for BELVIQ (lorcaserin hydrochloride (HCl)) tablets and BELVIQ XR (lorcaserin HCl) extended-release tablets which were originally approved by FDA on June 27, 2012 and July 15, 2016, respectively. This announcement was made on the Federal Register’s prepublication page (here) The official withdrawal will be effective the date of the final FR publication tomorrow.
The withdrawal comes after a series of events related to safety of these products. On January 14, 2019, a Drug Safety Communication was issued by FDA based on the Agency’s concern that the products may possibly cause cancer. This concern arose from an assessment of a clinical trial designed to determine whether the products had a risk of heart-related issues. The study revealed the possible cancer risk. On February 13, 2020, the Agency asked the firm to withdraw the applications of the weight loss drug products as they were shown in a clinical study to cause an increased risk of cancer. The firm requested that the Agency withdraw approval of the products the same day and waived the firm’s opportunity for a hearing. Additional background information from the February 13, 2020 Safety Communication may be found here.
This notice finalizes the withdrawal of the products for safety reasons, meaning that the FDA will not accept or approve any ANDAs for copies of these products. According to the Paragraph IV database (here), there were four ANDAs submitted as first filers on June 27, 2016 for the immediate release tablets and one first filer ANDA submitted on December 13, 2016.
