Malvern-Based Endo’s FDA Lawsuit Up in the Air After Government Shutdown

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Endo International’s lawsuit against the Food and Drug Administration has been indefinitely delayed after the government shutdown, writes John George for the Philadelphia Business Journal.

The Dublin-based company with its U.S. headquarters in Malvern sued the FDA in October 2017. Endo alleges that the agency acted in violation of federal statutes when it authorized the bulk compounding of a number of drugs, including vasopressin.

Compounding in this case refers to creating a medication specifically tailored to an individual patient by altering the existing drug’s ingredients, or combining them with others.

Endo previously agreed to a delay until Dec. 31. In return, the FDA committed to doing its best to issue a final clinical determination for vasopressin manufactured by Endo subsidiary Par Sterile Products on or before that date.

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However, the FDA filed a new motion, asking for a further delay until the government regains its funding. In the meantime, the Department of Justice attorneys and the FDA employees in charge of handling Endo’s litigation are prohibited from working for the duration of the government shutdown, except under very limited circumstances.

Endo did not oppose the motion.

Read more about Endo in the Philadelphia Business Journal here.

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