On September 12, 2012, the U.S. Food and Drug Administration (“FDA”) announced the approval of the drug Aubagio (teriflunomide). Manufactured by Sanofi Aventis, Aubagio is a once-a-day tablet for the treatment of relapsing forms of multiple sclerosis (“MS”) in adults. …
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 connection with promoting unapproved products as drugs. According to the FDA, the firms cited by the Agency, PruTect Rx and …
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 specifically to treat children with a rare type of brain tumor, known as subependymal giant cell astrocytoma (SEGA). Manufactured by …
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 treat the HIV-1 infection in adult individuals who have not previously received treatment for the infection. Manufactured by Gilead Sciences, …
FDA Publishes Final Guidance Explaining Egg Safety Rule
On August 20, 2012, the U.S. Food and Drug Administration (“FDA”) announced the availability of the final guidance document entitled “Guidance for Industry: Questions and Answers Regarding the Final Rule, Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, …
Listeria-Laden Onions Spur Recalls throughout United States
On July 28, 2012, the U.S. Food and Drug Administration (“FDA”) published a press release notifying consumers of a voluntary recall initiated by GH Foods CA, LLC. The recall covers a variety of products containing certain onions distributed by Gills …
FDA Proposes New Unique Identifier System for Medical Devices
On July 3, 2012, the U.S. Food and Drug Administration (“FDA”) announced its intention to require most medical devices in the United States to bear a Unique Device Identifier (“UDI”). According to the FDA, this UDI system could potentially improve …
FDA Approves First At-Home HIV Test
On July 3, 2012, the U.S. Food and Drug Administration (“FDA”) approved the first over-the-counter (“OTC”) at-home test kit used to detect human immunodeficiency virus (“HIV”). According to the FDA’s announcement, the OraQuick In-Home HIV Test allows the user 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 will result in the largest settlement of its kind in the United States. In particular, the pharmaceutical giant will be …
FDA Warns Makers of RockStar Coffee & Energy Products
On May 23, 2012, the U.S. Food and Drug Administration (“FDA”) issued a Warning Letter to the manufacturers of the widely popular RockStar energy products, Rockstar , Inc. (“the Company”). Found here, the Letter contains various allegations that the Company’s …