Wyeth sues FDA to halt release of generic version of antibiotic

//September 23, 2009//

Wyeth sues FDA to halt release of generic version of antibiotic

//September 23, 2009//

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Company claims version approved last week is based on discontinued formulation, may endanger patient health.Wyeth Pharmaceuticals, in Madison, filed a lawsuit Wednesday against the federal Food and Drug Administration to block the approval of a generic version of the company’s antibiotic Zosyn.

Wyeth’s complaint, filed in the U.S. District Court for the District of Columbia, asks for a halt to the FDA approval of abbreviated new drug applications for a generic version of Zosyn from Orchid Chemicals & Pharmaceuticals Ltd.

Orchid, in Tamil Nadu, India, said it received FDA approvals for the generic last Wednesday, but Wyeth claims this version cannot be safely used in the same manner as Zosyn, and endangers patient health.

Zosyn is an intravenous treatment for bacterial infections, and can be used in combination with other drugs. The complaint claims Orchid’s generic is based on a prior formulation that Wyeth no longer markets. The lack of certain ingredients changes its compatibility with other drugs, the complaint said.

Wyeth claims that the Orchid generic version cannot be safely interchanged for all types of dosings of Zosyn.

Wyeth said it is seeking a temporary restraining order and a preliminary injunction ordering FDA to withdraw or suspend its approval of the drug application.

The FDA said it is reviewing the complaint.

E-mail João-Pierre Ruth at [email protected]

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