. home.aspx

NEWS

home.aspx
   


The hits keep coming- Apotex loses 31 drug approvals after FDA cites plants for inadequate controls

July 10, 2019 / Kyle Blankenship

Its 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 The withdrawn approvals follow a warning letter issued in late 2018, Apotex's third in four years, which cited a lack of accuracy and integrity in the site’s data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 regul...