UPDATED: Issues at Chinese API maker undermine Lannett drug approval

A sign for the FDA building

The regulatory problems of a Chinese API maker have created issues for U.S. drugmaker Lannett, resulting in the withdrawal of an approval for a chemo drug. But instead of suing its API partner, Lannett has sued the FDA.

The lawsuit, filed in federal court last week, says the agency denied its constitutional rights by rescinding the approval of an ANDA for temozolomide capsules without a hearing, the Legal Intelligencer reports. It says the company had voluntarily agreed not to manufacture its product after learning the FDA found issues at its API maker, Chongqing Lummy Pharmaceutical, but that the FDA instead rescinded the approval after learning of its own mistake.  

The suit says the generic drugmaker identified Chongqing Lummy Pharmaceutical as its API maker when it filed its drug application in 2011, the Intelligencer reports. It claims the FDA inspected Chongqing Lummy’s plant in February and a week later approved Lannett’s application. Lannett ($LCI) announced the approval in a press release.

But in April, the FDA notified Lannett that because of manufacturing issues at the Chinese plant, the FDA would not allow release of the ingredient until the facility met FDA standards. Citing the lawsuit, the Intelligencer said Lannett disagreed but the FDA followed up with a letter saying that "due to review and endorsement process errors," the application had been mistakenly approved but that an inspection of the manufacturing facility found issues and that the approval of the application should have been withheld.

The FDA last week posted a June warning letter to Chongqing Lummy that inspections of two plants uncovered widespread and serious data manipulation of batch analyses. It found that the company routinely retested samples without justification and deleted raw analytical data from computerized systems that did not provide the results that were needed.

An FDA spokesperson acknowledged the FDA's erred in approving the med, saying: "Rescissions of approval are extremely rare. The FDA has completed a comprehensive internal review of the factors that led to this erroneous approval and continues to evaluate measures to prevent recurrence."

- read the Legal Intelligencer story
- here's Lannett's temozolomide announcement

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