Pfizer asks FDA to recall Teva, Sandoz generic azithromycin

By Lisa Kerner

Erie, Pa., Feb. 8 - Pfizer Inc said it has filed a Citizen Petition alerting the Food and Drug Administration that generic azithromycin products sold by Teva Pharmaceuticals U.S.A. and Sandoz Inc. appear to be misbranded because their labels do not accurately describe the drugs' active ingredients.

Pfizer is asking that the products be recalled to correct their misbranding, according to a company news release.

The company has also brought patent infringement actions against the two companies claiming that these products violate a Pfizer patent.

The Teva and Sandoz drugs are generic versions of Pfizer's antibiotic Zithromax, the company said.

Pfizer said it also asked the FDA to review the product approval applications filed by Teva and Sandoz and to take appropriate remedial action if necessary.

"Patients and physicians must be able to trust that the medicine in the bottle is the same as that which is described in the label," Pfizer chairman and chief executive officer Hank McKinnell said in the release. "Pfizer wants to ensure that patients do not receive generic products that fail to meet FDA standards."

Regarding the patent infringement actions, Pfizer claims that the Teva and Sandoz products violate a recently issued Pfizer patent covering azithromycin sesquihydrate and is requesting court-imposed preliminary and permanent injunctions against further sales of the drugs.

Pfizer alleges that the drugs contain significant amounts of azithromycin sesquihydrate rather than the azithromycin monohydrate that they claim in their labels.

Both Pfizer's Zithromax and a generic azithromycin launched by the company's Greenstone subsidiary contain azithromycin dihydrate, which is the product approved in Pfizer's New Drug Application.

Zithromax's composition-of-matter patent in the United States expired in November. Teva, Sandoz and Greenstone launched their generic products that same month. Pfizer said it will continue to market its generic azithromycin through Greenstone.

New York-based Pfizer engages in the discovery, development, manufacture and marketing of prescription medicines.

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