The world’s biggest drug maker Pfizer alleges that the drugs contain significant amounts of azithromycin sesquihydrate rather than the azithromycin monohydrate that they claim in their labels.
Pfizer’s Zithromax contains azithromycin dihydrate, which is the product approved in Pfizer’s New Drug Application.
Apart from asking the FDA to recall the products, Pfizer is also asking the agency to review the product approval applications filed by the two companies to ensure the information contained within them is accurate and complete.
Pfizer also has brought patent infringement actions against the two companies claiming that these products violate a recently-issued Pfizer patent.
“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,” said Hank McKinnell, Pfizer chairman and CEO. “Pfizer wants to ensure that patients do not receive generic products that fail to meet FDA standards.”