NDA
FDA Stops Company from Marketing Unapproved New Drugs
On January 30, 2015, and at the request of the U.S. Food and Drug Administration (FDA), a federal judge granted…
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…
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…
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.…
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…
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…
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…