Wyeth sues to block generic antibiotic

September 23, 2009 7:53:21 AM PDT
Drugmaker Wyeth on Wednesday sued the Food and Drug Administration to block the sale of a generic rival to its intravenous antibiotic Zosyn, claiming the generic is not an equivalent product and could harm critically ill patients. Wyeth filed a federal lawsuit against the FDA, seeking both a temporary restraining order and a preliminary injunction. The lawsuit seeks to prevent Orchid Pharmaceuticals from selling a generic version of Zosyn that the FDA approved last week. Wyeth's head of global medical affairs, Joe Camardo, said

patient safety is at stake and that Orchid's product could lead to preventable medical errors.

"Over 2 million people get Zosyn in any given year," Camardo told The Associated Press in an interview.

Many of those are critically ill patients with very serious infections, so hospital workers are rushing to set up an intravenous line to rapidly feed in both Zosyn and a standard IV solution to boost blood volume, he said. The problem is that with an older formulation of Zosyn, which Wyeth claims is what Orchid is using, Zosyn can mix with the intravenous solution in a way that causes a chemical reaction that inactivates the antibiotic, limiting how much patients would get.

"They wouldn't get the full dose," Camardo said.

That could mean the patient doesn't have enough antibiotic to stop the infection.

In addition, having two different versions of the same antibiotic on the market could cause confusion when hospital workers are rushing to save very ill patients, Madison, N.J.-based Wyeth said.

The lawsuit was filed in U.S. District Court in Washington, D.C.

The 33-page suit names as defendants the FDA, the U.S. Department of Health and Human Services and its head, Secretary Kathleen Sebelius, and Dr. Margaret Hamburg, commissioner of the FDA.

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