Wyeth Sues FDA Seeking to Block Generic Rival to Antibiotic Zosyn

Wyeth, one of the world’s largest drug makers, filed a lawsuit today against the Food and Drug Administration seeking to block a newly approved generic drug that would compete with Wyeth’s antibiotic drug Zosyn.

Wyeth claims the generic form of its drug, Zosyn, made by Orchid Chemicals & Pharmaceuticals Ltd. of Chennai, India is a dangerous knock-off based on a no-longer-used formulation of the drug that could pose a risk of injury to critically ill patients who use the cheaper generic form of the drug instead of the brand-name version.

The FDA granted approvals to generic Zosyn last week but Wyeth is seeking a temporary restraining order and injunctions to prevent it from going on sale. The lawsuit was filed in U.S. District Court in Washington, D.C., according to an Associated Press news report.

According to Wyeth, more than two million people are prescribed Zosyn each year, so the risk of injury to patients who take Orchid’s generic product instead is immense. Zosyn is known chemically as piperacillin and tazobactam.

Most people who take Zosyn are critically ill with severe infections. The drug is administered intravenously to speed its effects. According to Wyeth’s suit, Orchid used an older formulation of Zosyn to create the generic form the company now wants to sell.

That older formulation, which Wyeth stopped using in October 2005, may negatively react with chemicals in intravenous solution used to deliver Zosyn and cause the antibiotic to become partially inactive, reducing the infection-fighting benefits given to patients, Wyeth said.

That could mean the patient doesn’t get enough antibiotic to stop the infection in time, Wyeth said.

Also, Wyeth contends that having two Zosyn versions in use at the same time could cause confusion among hospital workers rushing to save very ill patients, a Wyeth spokesman told the AP.

Zosyn has been available in the United States since 1993 and had 2008 sales totaling $1.3 billion, making it Wyeth’s fifth-biggest product line.

Orchid has made generic drugs, particularly antibiotics, since 1994 and ranks among India’s top 15 pharmaceutical companies, according to the AP. The company plans market some of its new drugs in partnership with another generic drugmaker, Canada’s Apotex Inc, the AP said.

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