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Drugs

FDA/FTC Issue Joint Warning Letter to Company Marketing Flu Remedy

On January 24, 2013, the U.S. Food and Drug Administration (“FDA”) and the U.S. Federal Trade Commission (“FTC”) issued a…

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 Targets Online Pharmacies in International Efforts

On October 4, 2012, the U.S. Food and Drug Administration (“FDA”) announced that it has taken action as part of…

FDA Approves MS Drug, Noting Boxed Warnings

On September 12, 2012, the U.S. Food and Drug Administration (“FDA”) announced the approval of the drug Aubagio (teriflunomide). Manufactured…

FDA Warns Dietary Supplement Firms for Marketing Concussion Treatments

On September 6, 2012, the U.S. Food and Drug Administration (“FDA”) issued warning letters to two dietary supplement companies in…

FDA Approves First Drug Specifically Formulated to Treat Pediatric Tumors

On August 29, 2012, the U.S. Food and Drug Administration (“FDA”) announced the Agency’s approval of a new drug formulated…

FDA Approved Combination Pill for HIV Treatment

On August 27, 2012, the U.S. Food and Drug Administration (“FDA”) announced the approval of Stribild, a drug intended to…

GlaxoSmithKline to Pay $3 Billion in Settlement with Government

On July 2, 2012, GlaxoSmithKline (“GSK”) announced its intention to plead guilty in its ongoing healthcare fraud case in what…

House Oversight Committee Finds that FDA Actions Cause Drug Shortages

On June 15, 2012, the U.S. House of Representatives Committee on Oversight and Government Reform issued a Staff Report, detailing…

Marshals Seize Misbranded Drug Products at Maine Facility per FDA’s Request

On June 6, 2012, the U.S. Food and Drug Administration (“FDA”) announced the seizure of various drug products from a…