FDA News Digest
May 12, 2008 _____________________________________
IN THIS WEEK’S ISSUE
— Generic Versions of Restless Legs Syndrome Treatment Approved
— FDA OKs Room Temperature Formulation of Blood Clotting Therapy
» Congressional Testimony
» Safety Alerts/Recalls
Generic Versions of Restless Legs Syndrome Treatment Approved
FDA has approved the first generic versions of Requip (ropinirole hydrochloride) tablets for the treatment of moderate-to-severe restless legs syndrome. The approval covers a variety of dosages. Four companies have received approval to market the tablets.
FDA OKs Room Temperature Formulation of Blood Clotting Therapy
FDA has approved a new formulation of the genetically engineered version of Factor VIIa, used to treat bleeding and prevent surgical bleeding in patients with hemophilia A or B. The new formulation allows the product to be stored at room temperature (up to 77 degrees Fahrenheit) for up to two years. This is helpful for healthcare facilities with limited refrigerated space, and it allows greater flexibility in disease management for both patients and doctors.
May 1 — FDA Center for Drug Evaluation and Research Director Janet Woodcock, M.D., appeared before the House Subcommittee on Health.
Subject: “Discussion Draft of The ‘Food And Drug Administration Globalization Act’ Legislation: Drug Safety”
April 29 — FDA Center for Drug Evaluation and Research Director Janet Woodcock, M.D., appeared before the House Subcommittee on Oversight and Investigations.
Subject: FDA‘s ongoing heparin investigation
› Little Bay Baking and GFCFDiet Corn Bread and Muffin Mix, 12.6-oz. size
Reason for recall: may contain soy not declared on the label
For a list of recalls, market withdrawals, and safety alerts involving FDA-regulated
products from the past 60 days, go to http://www.fda.gov/opacom/7alerts.html.