FDA: RLS Treatment Approved. Corn Bread & Muffin Mix Recall

FDA News Digest

May 12, 2008 _____________________________________

IN THIS WEEK’S ISSUE

»  News

    — Generic Versions of Restless Legs Syndrome Treatment Approved

    — FDA OKs Room Temperature Formulation of Blood Clotting Therapy

»  Congressional Testimony

»  Safety Alerts/Recalls

 

NEWS

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.

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01832.html

 

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.

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01833.html

CONGRESSIONAL TESTIMONY

 

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”

http://www.fda.gov/ola/2008/fdaglobalact050108.html

 

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

http://www.fda.gov/ola/2008/heparin042908.html

  SAFETY ALERTS/RECALLS

Food Recall:

› 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

http://www.fda.gov/oc/po/firmrecalls/littlebay05_08.html

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.