jueves, 2 de julio de 2015

Drug Information Update - Federal judge enters permanent injunction against Acino Products, LLC

FDA Division of Drug Information: Know the Moment It Happens
The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.

A federal judge for the District of New Jersey has entered a consent decree of permanent injunction between the United States and Acino Products LLC (Acino), of Hamilton, New Jersey, and the company’s president, Ravi Deshpande, for marketing unapproved and misbranded prescription drugs.
The U.S. Department of Justice brought the action on behalf of the U.S. Food and Drug Administration.
According to the complaint, Acino marketed unapproved prescription drugs, hydrocortisone acetate 25 mg suppositories under the brand names Rectacort-HC and GRx HiCort 25, for treatment of medical conditions including inflamed hemorrhoids, chronic ulcerative colitis, and other inflammatory conditions.
Rectacort-HC and GRx HiCort 25 have not been approved by the FDA. In addition, these prescription drugs are misbranded because their labeling fails to carry adequate directions for use. Unapproved new drugs and misbranded drugs have not been shown to be safe and effective, may be of uncertain quality, and may pose risks to patients.

No hay comentarios: