post-marketing studies

FDA Approves First Drug Specifically Formulated to Treat Pediatric Tumors

FDA Accelerated Approval Program, Drug, Drugs, FDA, Pediatric, post-marketing studies

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 Novartis, Afinitor Disperz is a new dosage form of the existing anti-cancer drug Afinitor. While approved by the FDA in November 2010, Afinitor was for use only in patients three years of age and older. With this new approval, Afinitor Disperz is recommended for use by patients ages 1 and older. This approval is significant in that Afinitor Disperz is…

GlaxoSmithKline to Pay $3 Billion in Settlement with Government

FDA Drugs, Enforcement, FDA, GlaxoSmithKline, off-label promotion, off-label use, post-marketing studies

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 pleading guilty to marketing two of its drugs, Paxil and Wellbutrin, for unapproved uses and for failing to report post-marketing safety issues associated with its diabetes drug Avandia. In addition to the hefty fine, totaling some $3 billion dollars, GlaxoSmithKline will be subject to continued monitoring by the government for the next five (5) years. GSK's( GlaxoSmithKline ) Press Release discussing…