NDA

• FDA

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

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

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…

• FDA

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

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

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

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…