FDA Postpones Hearing on Use of Pegintron for Skin Cancer

By Alice Turner
21:19, March 10th 2008
69 votes
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FDA Postpones Hearing on Use of Pegintron for Skin Cancer

One of the advisory panels of the U.S. Food and Drug Administration has postponed its planned meeting on the use of Pegintron (Peginterferon alfa-2b) in cases of skin cancer. The drug is made by Schering-Plough. The advisers were to meet on Wednesday, but a Schering-Plough spokeswoman told Reuters that the FDA is seeking clarification of existing data and no new date for the hearing had been set.

Also, the regulators said that the company's Bridion, an injectable drug designed to reverse the effects of anesthesia in patients after surgery, appears to be effective. A special panel will meet next Tuesday to review the drug. While the drug appears safe for adults, more information is needed on potential allergic reactions and the drug's effects on children's teeth. Animal tests showed it intefered with the formation of enamel.

Pegintron was approved by the FDA for the treatment of chronic hepatitis C in patients not previously treated with interferon alfa who have compensated liver disease and are at least 18 years of age. It is believed to be of help in skin cancer, the fastest growing type of cancer in the United States and the most commonly diagnosed malignancy.

Also, the FDA warned six companies to stop marketing unapproved drugs which the makers say are meant for treating and preventing sexually transmitted diseases. The unapproved products are Tetrasil, Genisil, Aviralex, OXi-MED, Imulux, Beta-mannan, Micronutrient, Qina, and SlicPlus. Their makers are Aviralex International of San Francisco; Aidance Skincare & Topical Solutions LLC. of Harmony, R.I.; health-science-report.com; NeumaLife of Boys Town, Neb.; IMULUX LLC. of Fort Smith, Ark.; the Saferex Laboratories International Corp. of Sachse, Texas; and Waldon Research of Christchurch, New Zealand.



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