FDA consent decree with Ascend Labs backed by federal judge
A federal judge from the US District Court for the Southern District of Ohio entered a consent decree for permanent injunction against Ascend Laboratories. The US Department of Justice filed the consent decree on behalf of the Food and Drug Administration.
The consent decree requires Ascend Laboratories to post bond for the release of its unapproved drug products seized by US 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 (doing business as RXTPL).
May not make or distribute certain products until approved by FDA
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