The U.S. Food and Drug Administration today approved a new device that provides neurointerventional surgeons with another tool to treat brain aneurysms without performing open surgery.

On April 6, the U.S. Food and Drug Administration approved Horizant Extended Release Tablets (gabapentin enacarbil), a once-daily treatment for moderate-to-severe restless legs syndrome (RLS).

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U.S. Marshals seize drug products manufactured and distributed by Wisconsin firms

Beginning today, consumers can search for food and other product recalls easier and quicker on FDA’s website than previously. The FDA Food Safety Modernization Act (FSMA) signed into law in January by President Obama called for a more consumer-friendly recall search engine. DSK

The U.S. Food and Drug Administration today issued two proposed regulations regarding calorie labeling on menus and menu boards in chain restaurants, retail food establishments, and vending machines. The FDA invites input on the proposed regulations by visiting http://www.regulations.gov. (SY)

On February 3, 2011, the Food and Drug Administration approved the drug Makena (hydroxyprogesterone caproate) for the reduction of the risk of certain preterm births in women who have had at least one prior preterm birth. KV Pharmaceuticals, the drug’s owner, received considerable assistance from the federal government in connection with the development of Makena by relying on research funded by the National Institutes of Health to demonstrate the drug’s effectiveness. It also obtained seven years of exclusivity under the Orphan Drug Act, obtained approval under FDA’s accelerated approval program, and received expedited review.

In response to the ongoing situation in Japan, the U.S. Environmental Protection Agency has taken steps to increase the level of nationwide monitoring of milk, precipitation, drinking water, and other potential exposure routes.

The U.S. Food and Drug Administration is warning consumers to stop using Soladek, a vitamin-solution product marketed by Indo Pharma, S.A., of the Dominican Republic, because the product may contain dangerously high levels of vitamins A and D.
Soladek is marketed with claims that the product treats “hypo and avitaminosis, rickets, growth, dentition, lactation, fractures, infection, convalescence, protection and regeneration of certain epithelium (bronchial, glandular, ocular, cutaneous), corticotherapy, aging and pregnancy.” The product is sold in a box labeled in Spanish and containing a vial of the solution.

The U.S. Food and Drug Administration today approved Yervoy (ipilimumab) to treat patients with late-stage (metastatic) melanoma, the most dangerous type of skin cancer.