Teva Pharma has fallen 6% following reports that it will not be able to access the FDA’s approval of its experimental cancer drug, AZT, for use in India.
The drug was approved in 2014, but the US government has yet to approve it for the treatment of colorectal cancer.
Last month, the FDA granted Teva the waiver to test its AZT on colorecctal cancers in India, but has yet said whether it will also allow the drug to be used on other cancers.
Teva, the world’s third-largest pharma company by market value, said in a statement on Monday that it has asked the FDA to “revoke its waiver to initiate the trial.”
The company said that it plans to send the drug for trial to the US soon.
The company did not say how many patients would be eligible to receive the treatment, but it said it expects “to receive a positive response from a subset of patients.”
The FDA has not yet said how long the trial will take to complete, and Teva has not indicated how many people in India will be enrolled in the trial.
The FDA said it will allow the trial to begin in a month, but declined to give a time frame.
The agency has asked for a detailed analysis of the trial results before making a final decision on whether to approve the drug, which is currently under development in the US.
The agency’s chief medical officer, Dr. Margaret Chan, has said that Teva is aiming to complete the trial by March or April.
The US FDA, which has approved the drug in two other cases, has not issued a public statement on Teva’s request.
Last week, Teva said that the trials will begin within two months, but that it expects to get positive responses from a “small subset of” patients.
The trial is being conducted by Dr. Pramod Patel, the chairman of Teva, and Dr. Ramesh Kumar, the chief medical scientist.
According to the FDA, the trial is a continuation of Tevatron’s Phase III trials, which began in 2012 and were designed to test the safety of AZT in treating coloreecal cancers.
In August, the company said in an email to investors that it had received a “positive response” from 1,500 patients.
It said it had not yet reached a conclusion on whether it would be able access the full approval.
Tevatron is a rare compound that can treat some cancers, including breast and prostate, and is used in some patients with other cancers, such as lung, skin and throat.
In a statement, Tevador, the largest pharmaceutical company in India and the world, said that, after the trial’s completion, it would “continue its work to reach a mutually agreeable settlement with the US FDA and ensure the safety and efficacy of the drug.”
The company said it was “extremely disappointed” by the FDA decision.
“We are disappointed that the FDA is choosing to continue with a trial that is still in progress, even after Tevitar’s application has been approved by the US and the FDA has concluded its Phase III trial, which Tevadores application has not,” the company added.