Endo comes out on top in its fight with FDA and bulk compounder

Endo comes out on top in its fight with FDA and bulk compounder

While Endo International continues to face big legal challenges tied to opioid production, the drugmaker has prevailed in its two-front fight with the FDA and bulk compounders. The resolution has ended competition for its vessel constrictor Vasostrict.

The drugmaker today said that it has dropped its litigation against the FDA, which was filed in 2017 when the agency looked to have opened the floodgates for bulk compounders to make their own versions of vasopressin, the API for Vasosrict, a drug that generated $453 million for Endo last year. When the FDA amended its draft guidelines to stop compounders from making vasopressin, one of those compounders sued the FDA and Endo then joined the FDA in that fight.

Vasopressin labeled.png

Endo today said that a federal court in August upheld the FDA’s decision to prevent compounding of vasopressin and that Ahtenex, the compounder that sued, has now dropped its appeal. With the competition put to rest, Endo said it was comfortable dismissing its litigation with the FDA.

Endo made nice by congratulating the FDA for its “successful and well-reasoned implementation” of Section 503B of the drug quality safety act.

“In light of FDA’s determination that bulk compounding of vasopressin is impermissible under Section 503B and the Court’s decision to uphold that determination, we have agreed with the Department of Justice and the FDA to voluntarily dismiss Endo’s lawsuit,” Matthew J. Maletta, Endo’s chief legal officer said in a statement.

While the ruling is specific to vasopressin, it is believed to have precedent for other drugmakers whose drugs are targeted by large-scale compounders for generic competition.

The resolution of this legal battle comes as Endo is in the process of also settling litigation with some counties in Ohio over the manufacturing of its opioid products.

Sep 30, 2019

https://www.fiercepharma.com/

 

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September 30, 2019 / Pharma News