Regulatory and Drug Approvals News

Xanodyne Pharmaceuticals, Inc., an integrated specialty pharmaceutical company with both development and commercial capabilities focused on women's healthcare and pain management, announced today that Lysteda(TM) (tranexamic acid) oral tablets has received U.S.

The U.S. Food and Drug Administration has approved the use of the CSL Limited's seasonal and 2009 H1N1 influenza vaccines to include children ages 6 months and older.

Apogenix GmbH, a biopharmaceutical company developing novel drugs for malignant and inflammatory diseases, announced that the European Medicines Agency adopted a positive opinion on orphan medicinal product designation for the company's lead candidate APG101 for the treatment of Glioblastoma multifome (GBM), and that it has already been granted orphan drug status in the US by the US Food and Drug

Several weeks ago, the FDA announced its intent to change, by summer 2011, its policy regarding the post-harvest processing of raw Gulf Coast oysters harvested in the warmer months.

The Food and Drug Administration's Center for Food Safety and Applied Nutrition (CFSAN) today released a report from the Institute of Food Technologists (IFT), which recommends clear objectives be set for all users of a simpler, globally accepted food supply chain that can benefit from existing commercial systems.

The Food and Drug Administration today notified nearly 30 manufacturers of caffeinated alcoholic beverages that it intends to look into the safety and legality of their products.

The U.S. Department of Justice, on behalf of the U.S. Food and Drug Administration, has filed a complaint for permanent injunction against seafood processor Haifa Smoked Fish Inc. of Jamaica, N.Y., and two of its top officers for violations of the Federal Food, Drug and Cosmetic Act.

An overwhelming majority of New Hampshire voters - 90 percent - support food safety legislation that would give the Food and Drug Administration (FDA) new authority to ensure the food Americans eat does not make them sick, according to a new poll commissioned by the Pew Health Group and conducted by Hart Research and Public Opinion Strategies.

Cadence Pharmaceuticals, Inc. (Nasdaq: CADX) announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for its Priority Review of the New Drug Application (NDA) for intravenous (IV) acetaminophen by three months. The extended PDUFA goal date is February 12, 2010.

The U.S. Food and Drug Administration approved Lysteda tablets (tranexamic acid), the first non-hormonal product cleared to treat heavy menstrual bleeding (menorrhagia). Lysteda works by stabilizing a protein that helps blood to clot. Heavy menstrual bleeding is reported each year by about 3 million U.S. women of reproductive age.