On January 30, 2015, and at the request of the U.S. Food and Drug Administration (FDA), a federal judge granted a consent decree of permanent injunction against Laclede, a U.S.-based manufacturer in connection with the marketing of unapproved new drugs. …
FDA Approval Required for Company Enjoined from Marketing Products
On October 10, 2014, a federal judge from the U.S. District Court for the Southern District of Ohio sided with the U.S. Food & Drug Administration (“FDA”) and entered a consent decree for permanent injunction against Ascend Laboratories, LLC. As …
FDA Seizes Topical Creams Deemed Drugs
On May 16, 2014, the U.S. Food and Drug Administration (“FDA”), with assistance by the U.S. Attorney for the Southern District of Ohio, seized unapproved drugs valued at more than $11 million, which were marked by Ascend Laboratories of Montvale, …
Supreme Court to Review Design Defect Case against Generic Drug Company
On March 19, 2013, the U.S. Supreme Court will hear arguments in Mutual Pharmaceutical Company, Inc. v. Karen L. Bartlett. The defendant-appellant in the case, Mutual Pharmaceutical Company (“Mutual”) appealed from a decision of the U.S. Court of Appeals for …
FDA Approves Bladder Control Drug for OTC Use, Highlighting Rx to OTC Switch
On January 25, 2013, the U.S. Food and Drug Administration (“FDA”) announced the approval of the first women’s bladder control product available without a doctor’s prescription. In the past, all bladder control drugs were only available by prescription. This product, …
FDA Approves Drug for Treatment of Plague Through Animal Efficacy Rule
On April 27, 2012, the U.S. Food and Drug Administration (“FDA”) approved Levaquin (levofloxacin), a drug used to treat those afflicted with plague. In addition to treating those with the deadly infection, Levaquin is also approved to reduce the risk …
FDA Approves Vivus Inc.’s Stendra to Treat Erectile Dysfunction
On April 27, 2012, the U.S. Food and Drug Administration (“FDA”) approved the drug Stendra (avanafil), a drug used to treat erectile dysfunction (“ED”). Marketed by Vivus, Inc., Stendra is intended to be taken by men on an as-needed basis …