The makers of an antibiotic marketed by Jansen Pharmaceuticals are calling it “strict and consistent” and are promising to abide by strict safety and quality requirements.
The company said Tuesday that it has submitted a list of “non-compliance” points to the U.S. Food and Drug Administration, the first step in a process that would allow it to move forward with an FDA review.
“Janssen is focused on developing the most effective antibiotic to protect the American people and minimize the number of infections caused by this potentially life-threatening condition,” the company said in a statement.
“The FDA will conduct an initial review and will provide a more detailed report once the list is submitted.”
FDA officials have not publicly discussed the FDA’s plans for a review of Jansens antibiotic.
But the drugmaker’s website says it is “stressing the importance of the FDA taking appropriate action to ensure the safety and efficacy of our product and is committed to ensuring that its labeling reflects these standards.”
The company also says it has agreed to submit a list with the FDA for review and comment.
In a statement, FDA officials said the agency “continues to assess potential safety issues, and we will respond in a timely fashion when we have more information.”
FDA spokesman Tom Hayes declined to say how long it would take for Jansus to respond to the FDA.
FDA officials, however, said in December that they would look into the antibiotic.
Janssens chief executive officer Chris Burd said the company’s goal was to “work with the industry to ensure that the drug meets the FDA and the industry’s standards” and that it is working with a small number of industry-recognized safety authorities, including the European Medicines Agency, to ensure compliance.
Burd also said the FDA is looking at Jansson’s “compliance with existing safety standards and protocols” and “ensuring that we do not have any additional approvals.”
The FDA has previously declined to comment on the antibiotic because it’s under review.
Bids for a safety review of a new drug by Janesons are due Feb. 19, the day before the agency is scheduled to release its final draft of guidelines for new antibiotics.
The FDA is scheduled for a public meeting on Feb. 27 about the safety of the drug, and it will consider comments on the proposed guidelines for a final draft, which will be released March 9.
Janesens shares fell more than 7% in after-hours trading Tuesday, after the company told investors that it would have to revise its guidance for the drug because of the delay in the FDA review, which it blamed on “an unforeseen event.”
Burd did not provide an explanation for the delay.
The U.K.-based drugmaker said in an email that it “had not received a formal response” from the FDA but that it’s committed to following all the regulatory requirements in place to ensure all drug safety requirements are met.
“In light of the pending FDA review of our antibiotic, we have not yet had a formal opportunity to address the issue and we are committed to responding as soon as we have the opportunity,” the email said.
JaniSens shares rose more than 3% after the FDA said it would begin a safety and safety review.
The stock has lost more than 8% this year.
Jana International Inc., a British-based drug company that manufactures and sells another Jansuns drug, is also working with FDA officials to ensure Jansies antibiotic meets the agency’s safety requirements.
In an interview Tuesday, Jana Chief Executive Stephen Jana said that Jansys antibiotic is “safe, well-tolerated, well tolerated and well-tested.”
“We will work with the regulator to ensure it is approved,” he said.
“It is our view that the product is safe and that there is no risk associated with the use of this product.
We are hopeful that the FDA will take the time to look at our information and our response.”
Jana has a long history of success with the company, which has a global network of pharmacies and offices that help to deliver more than $3 billion worth of antibiotics to the global pharmaceutical industry each year.
In 2014, the company announced it would use its U.N. headquarters in New York to launch a new antibiotic.
The announcement prompted some investors to question Jana’s ability to successfully sell its drug and its ability to stay profitable.
Janas drugs have been used in many clinical trials worldwide, and they are used in more than 60 million people worldwide.
But Jansons antibiotics are often not approved for use in the United States because they are deemed too weak or too dangerous to treat.
In 2016, the FDA rejected a bid by Jana to sell its antibiotic to a manufacturer, citing a “serious lack of scientific evidence” that it could be safely used.
The drugs are sold under the brand names Nivolumab and Seroquel. In