The hits keep coming: Apotex loses 31 drug approvals after FDA cites plants for 'inadequate' controls
Apotex lost 31 generic approvals from the FDA after multiple manufacturing deficiency warnings.
It’s been a troubled few years for Canadian generics maker Apotex after the unsolved murder of founder Barry Sherman and a possible sale in the works. Now, after multiple warnings from the FDA, Apotex faces a future without approvals for a big slice of its portfolio.
The FDA yanked 31 of Apotex’s generic drug nods Wednesday after the agency identified manufacturing deficiencies at two of the drugmaker’s India-based plants. The list of drugs that lost their FDA blessing includes the common blood pressure drugs valsartan and losartan, the antibiotic azithromycin and copycat Viagra.
The withdrawn approvals follow a warning letter issued in late 2018, Apotex's third in four years, which cited a lack of accuracy and integrity in the site’s data production. The drugs on the list were approved by the FDA between 2007 and 2014.
“FDA has previously communicated about the need for appropriate and global quality oversight to Apotex senior management during several regulatory meetings,” the agency said in its warning letter (PDF) in August. “These repeated failures at multiple sites demonstrate that management oversight and control over the manufacture of drugs is inadequate.”
Apotex valsartan and losartan products were among those pulled off the market in Australia and Canada amid the global recall of drugs in that class. Potential cancer-causing impurities were found in active ingredients used by multiple drugmakers around the world.
The FDA hit is just the latest in a series of troubling events at Apotex since the still-unsolved murder of Barry Sherman and his wife, Honey, at their suburban Toronto home in December 2017.
Almost immediately after the Shermans’ death, Apotex CEO Jeremy Desai announced he would step down. A Teva lawsuit had accused Desai of accepting the Israeli drugmaker’s trade secrets from his girlfriend. Apotex vice chairman and former CEO Jack Kay replaced Desai and the company promoted global generics president Jeff Watson to president and chief operating officer.
Despite resigning, Desai denied the allegations against him and filed a countersuit in March 2018. Teva and Desai settled the lawsuits in April 2018, and Desai now serves as president and CEO of Mandara Pharma, a cannabis-based research company.
With the company in turmoil, the Sherman family appointed a financial advisor in April to weigh options to sell the company, which could have been worth $3 billion at the time, according to Bloomberg.
In 2018, Apotex sold its businesses in five European countries to Aurobindo for €74 million ($83 million) to focus on sales in the Americas.
Jul 10, 2019https://www.fiercepharma.com/