Drugmaker Wyeth is suing the Food and Drug Administration to block India’s Orchid Chemicals & Pharmaceuticals from a selling a generic version of Zosyn, a powerful antibiotic used in intensive care medicine.
The lawsuit claims the FDA’s approval of Orchid’s generic products is “unlawful” and “arbitrary, capricious, an abuse of discretion,” adding that it “permits the marketing of a generic drug product that cannot be safely used in the same manner as the branded product’’ and “seriously endangers patient health.”
Wyeth markets a newer version of the drug and in 2005 discontinued the older version of Zosyn, known chemically as piperacillin and tazobactam, which Orchid has now secured permission from the FDA to sell.
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