The U.S. Food and Drug Administration [FDA] on Thursday delayed approval of Teva Pharmaceutical‘s (TEVA) biotechnology medicine Neutroval, a drug which boosts white blood cells for cancer patients undergoing chemotherapy.
The FDA said it has issued a Complete Response Letter requesting additional information from Teva needed to complete the review of applications for product approval.
The Complete Response Letter related to the Neutroval application requested several items which Teva is reviewing and will work with the FDA to determine the appropriate next steps regarding this application.
Teva said the FDA did not ask for additional clinical trials of the drug.
Shares of Petach Tikva, Israeli-based Teva gained 11 cents, or 0.21 percent, to $52.70 at 11:39 p.m. ET in Nasdaq composite trading
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