Wyeth sues FDA, seeking halt to generic Zosyn
* India's Orchid had won approval for generic
* Wyeth shares off 0.4 percent
NEW YORK, Sept 23 (Reuters) - Wyeth WYE.N has sued the U.S. Food and Drug Administration, claiming the agency's approval of a generic version of the drugmaker's blockbuster Zosyn antibiotic endangers patient health.
India's Orchid Chemicals (ORCD.BO) earlier this month won
approval to market its generic form of Zosyn, which had about
$1.3 billion in sales last year.
In its suit filed in the U.S. District Court for the District of Columbia, Wyeth said the generic version of Zosyn is based on a formulation that Wyeth no longer markets.
Wyeth's current formulation includes two "functional inactive ingredients ... that are critical to its compatibility with other frequently used drug products," the suit said.
Wyeth claimed the FDA's approval of the Orchid version was unlawful and requested a temporary restraining order or an injunction ordering the agency to withdraw or suspend its approval of Orchid's application.
An FDA spokesman said the agency does not comment on ongoing litigation.
Wyeth agreed earlier this year to be bought by rival Pfizer
Inc (PFE.N).
Wyeth shares were down 0.4 percent at $48.37 in morning trading on the New York Stock Exchange. (Reporting by Lewis Krauskopf, editing by Matthew Lewis)
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