Wyeth files lawsuit to block generic antibiotic

Wyeth Pharmaceuticals, Collegeville, Pa., filed a federal lawsuit to overturn the Food and Drug Administration's recent approval of a generic drug to treat severe bacterial infections.

The lawsuit, filed in federal court in Washington, alleges that the generic antibiotic produced by Orchid Chemicals and Pharmaceuticals and approved by the FDA on Sept. 15 is not a safe alternative to Wyeth's Zosyn. Differences “pose a serious risk of confusion and medication error if both versions are simultaneously in the marketplace,” according to the complaint, which also seeks a temporary restraining order. Satish Srinivasan, executive vice president of Orgenus Pharma, the U.S. subsidiary of Orchid, in an e-mail declined to comment on pending litigation. Christopher Kelly, a spokesman for the FDA, said the agency does not comment on pending litigation.

Wyeth said in its complaint that the generic, based on a discontinued formula, lacks ingredients needed for the antibiotic to be compatible with other drugs. Nearly half the 47.2 million doses of Zosyn administered in 2006 were done so with along with other pharmaceuticals, according to the complaint.

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