FDA Update: June 21, 2010
By Lori Clapper, Web Editor
J&J Hit With More Recalls
McNeil Consumer Healthcare has added five more product lots to its growing recall list. The latest includes four lots of Benedryl Allergy Ultratab tablets sold in the United States and one lot of Extra Strength Tylenol rapid-release gels, sold in the United States, Trinidad, Tobago, Bermuda, and Puerto Rico. This recall is a follow-up to the company's January 15 recall, from which these products were inadvertently omitted.
The January 15 recall was initiated in response to consumer complaints of a musty or moldy odor that has since been linked to the presence of trace amounts of a chemical called 2,4,6-tribromoanisole (TBA). After a thorough investigation, it was determined that the presence of TBA was the result of a breakdown of a chemical that is applied to wood used to build wooden pallets that transport and store product packaging materials.
For more information on the recall and to see the full recalled product list, click here.
New Treatment Holds Promise For Prostate Cancer
Last week, the FDA approved Jevtana (cabazitaxel), a chemotherapy drug used in combination with the steroid prednisone to treat men with prostate cancer. According to the FDA, Jevtana is the first treatment of its kind for advanced, hormone-refractory prostate cancer.
"Patients have few therapeutic options in this disease setting," said Richard Pazdur, M.D., director of the Office of Oncology Drug Products, part of the FDA's Center for Drug Evaluation and Research. "FDA was able to review and approve the application for Jevtana in 11 weeks, expediting the availability of this drug to men with prostate cancer."
Jevtana, which is marketed by Sanofi-Aventis, was reviewed under the FDA priority review program, an expedited, six-month program designed for drugs that could bring major advancements in treatment or provide treatment for a disease that doesn't have a treatment. Click here to read the FDA's announcement regarding Jevtana.
June Warning Letters
Several drug companies received warning letters this month, including Adamis Pharmaceuticals for an unapproved new drug and Homeopathy for Health for unauthorized products related to the H1N1 Flu virus. You can see these recent letters and a complete list other warning letters here.