Drug giant Pfizer Inc. has halted the sale of its generic drug Viagra after reports the drug maker had a "black eye inspection" in the United States.
Pfizer said Thursday it had "limited information" as to how the company's generic drugs had been dispensed, and has been told to "go back to the US market."
Pfizer said it had notified its US subsidiary, Teva Pharmaceutical Industries Ltd., on the condition that it acted promptly to stop the shipment of Viagra and other impotence drugs.
The company said Pfizer's order was based in part on information provided by the FDA, and in part on the company's decision to halt the sale of its drugs. The FDA said the drug had been recalled.
Viagra is the brand name of the drug Viagra. The drug's patent ended in 2003.
Pfizer said Viagra's sales were up by 10 percent over the past year.
In September, Pfizer said it would issue a written order to the FDA to review the information.
Teva Pharmaceutical Industries Ltd.
Pfizer said Thursday it had "limited information" as to how the company's drugs had been dispensed, and had been told to "go back to the US market."
Pfizer's announcement comes just days after the FDA approved Viagra for the treatment of erectile dysfunction in men.
Pfizer's decision to stop the shipment of the drug prompted more than a dozen companies to pull the drug off the market.
Pfizer's news release said the company had received information that the drug maker had been "black-boxed" by the FDA for failing to comply with U. S. Food and Drug Administration guidance.
The release also said Pfizer had "limited information" about the medicine's manufacturing processes and safety, and had been told to "go back to the US market."
In a statement, Pfizer said: "We continue to believe that the company is in compliance with FDA and European Pharmacopeia (EPI) standards.
"Pfizer is committed to ensuring that the manufacturing process is both safe and effective. Based on our review of the available information and the FDA's determination that Pfizer is in compliance, we will continue to vigorously defend the company's ability to continue to operate and expand its portfolio of innovative, well-known pharmaceutical products."
A Pfizer spokesperson said: "We have taken additional steps to ensure that all medicines that we use are appropriately handled and approved by FDA and European Medicines Agency (EMA).."
Shares of Pfizer fell 0.7 percent Thursday after Pfizer said it was halting its supply of the drug, and was "reviewing the situation" with regulators.
Pfizer says it has stopped shipments of the drug from India and the U. for four days because it knew a "black box warning" had been placed on the drug.The company's statement said Pfizer had notified Teva Pharmaceutical Industries Ltd. of the "black box" warning.
Teva said the FDA had advised it to immediately stop any shipments of the drug from entering the U. S., and had not notified Pfizer of any delays.
A statement from Pfizer said: "Pfizer continues to take timely action to ensure that all products and all forms of drug products are appropriately handled and approved by FDA and EMA."
Pfizer, which has been a major player in the drug industry for more than a decade, said it was "reviewing the situation" with regulators.
Pfizer said it had "limited information" as to how the company's drugs had been dispensed and that it had "limited information" as to how the FDA had issued the order.
The company said it had been informed of Pfizer's decision to suspend its supply of its drugs and it would be reviewing the situation.
Pfizer says it has stopped shipments from India and the U.In a statement, Pfizer said: "Pfizer continues to take timely action to ensure that all products and all forms of drug products are appropriately handled and approved by FDA and EMA.
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Viagra is an oral medication designed for the treatment of erectile dysfunction (ED) in men. It works by increasing blood flow to the penis, which can help achieve and maintain an erection sufficient for sexual activity.
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