Merck, the largest maker of antibacterial drugs, is having a bit of a rough week as the U.S. government looks to close an import ban on a product that is one of the best-selling antibiotics worldwide.
The company said Wednesday that it would not resume selling its antibiotic-free flu shot, which had been blocked since March due to a potential safety issue.
The shot is marketed as a non-steroidal anti-inflammatory drug, or NSAID, which the FDA says can be used to treat severe infections.
But the government has since determined that the shot is not effective against the flu.
Merck says it plans to reissue the vaccine in early October.
The FDA has ordered Merck to resume the vaccine within 30 days, but the company has yet to provide a timetable for doing so.
It said the company must continue to meet the agency’s requirements.
“The FDA continues to monitor the safety and effectiveness of Merck® vaccine and will issue a final decision in due course,” a company statement said.
The Obama administration said it was reviewing the FDA’s decision to halt the flu shot.
“We will continue to work with the U-S.
Fish and Wildlife Service and the U .
Department of Agriculture to develop a response to the FDA decision,” a Merck spokesperson said.
“Our focus is to ensure that the public is protected from the flu, and we remain confident that our product can continue to provide the safety, effectiveness, and affordability needed to provide patients with the protection they need to keep them safe.”
The FDA said it would allow Merck access to the flu vaccine, but not sell it.
The agency said it had also issued a temporary freeze on imports of the drug and has issued a blanket import ban for a further six months.