A federal judge from the U.S. District Court for the Southern District of Ohio entered a consent decree for permanent injunction against Ascend Laboratories of Montvale, New Jersey, on Oct. 10.
According to an FDA release, the consent decree requires Ascend Laboratories to post bond for the release of their unapproved drug products seized by U.S. Marshals in May 2014, which the company is then responsible for destroying under the FDA’s supervision. The drugs were seized at a warehouse in Cincinnati operated by Masters Pharmaceutical Inc. (doing business as RXTPL).
In addition, the consent decree prohibits Ascend Laboratories and all other associated parties involved with the company from manufacturing and distributing unapproved drugs until the company obtains FDA approval, including: Pramoxine-HC Otic Drops; Hydrocortisone Acetate Suppositories 25 milligrams; Urea Cream 39%; Urea Cream 40%; and Urea Lotion 40%.
“Manufacturing and distributing unapproved prescription drugs puts patients’ health at risk since they have not been found to be safe, effective or made using quality manufacturing practices,” said Ilisa Bernstein, acting director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “Companies that fall short of our requirements risk FDA action to stop the distribution of their products.”
Read the full release