Wyeth Sues FDA Seeking To Reverse Approval Of Generic Zosyn
September 23 2009 - 10:28AM
Dow Jones News
Wyeth (WYE) has filed a lawsuit against the U.S. Food and Drug
Administration seeking to reverse the agency's recent approval of a
generic version of the company's antibiotic Zosyn.
Wyeth claims the generic drug can't be safely used in the same
manner as the branded product, due to interactivity with another
drug that is sometimes used in conjunction with Zosyn, and would
seriously endanger patients' health. The suit was filed in U.S.
District Court for the District of Columbia.
The FDA approved on Sept. 16 a generic version of Zosyn from
Orchid Chemicals & Pharmaceuticals Ltd. (524372.BY) of India.
Orchid is to have a 180-day period of generic market exclusivity,
and has joined with Apotex Inc. of Canada to sell the drug.
Wyeth, Madison, N.J., had previously asked FDA not to approve
generic versions of Zosyn because they were based on an earlier
formulation of the drug, and Wyeth changed the formulation in 2005.
But the FDA recently concluded that the formulation wasn't
discontinued for safety and efficacy reasons, clearing the way for
generic approvals.
Zosyn had $1.3 billion in sales last year. Wyeth has agreed to
be acquired by Pfizer Inc. (PFE); the deal is expected to close by
the end of the year.
An FDA spokeswoman said the agency doesn't comment on
lawsuits.
-By Peter Loftus, Dow Jones Newswires; 215-656-8289;
peter.loftus@dowjones.com