FDA withdraws approval
UNITED STATES – According to an online news article published by www.raps.org, the FDA has withdrawn approval of 31 Apotex drug applications, citing concerns about the company’s manufacturing practices.
The United States Food and Drug Administration (FDA) recently announced its decision to withdraw 31 abbreviated new drug applications (ANDAs) for Apotex, the maker of numerous generic drugs, including, among others, generic versions of valsartan, Viagra, losartan, and azithromycin. The FDA discovered manufacturing deficiencies at two Apotex facilities, both of which are based in India. The two facilities are Apotex Research Private Ltd. and Apotex Pharmachem India Private Ltd. The FDA learned of concerns involving a material manufactured at both Apotex facilities.
The FDA’s decision to withdraw approval of 31 ANDAs comes after Apotex requested to withdraw the ANDAs in January 2018. Additionally, last year, the FDA issued a warning letter to Apotex Research Private citing concerns with the company’s quality unit. The company has been on “import alert” since April 2018.
The FDA asserts that the company did not adequately investigate out-of-specification (OOC) laboratory results, failing to provide scientifically supported conclusions. Additionally, an FDA inspector discovered that a quality control microbiologist was seen altering dates on the material to make it appear the material had been tested on a previous date.
Apotex Research Private also received a warning letter in January 2015, while Apotex Pharmachem received a warning letter in June 2014, which was closed out in December 2016. Health Canada, the country’s food and drug regulatory agency, has raised concerns about the two Apotex facilities.
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