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New Prescription Medicine Updates
Below is a list of new, federally approved prescription medications helping you keep up-to-date on medical breakthroughs that contribute to a greater quality of life, and underscore the investment of time and expense of developing and bringing these products to the market.

To view a PDF of previous issues 2003 2004 2005 2008

ARZERRA
ARZERRA is a monoclonal antibody that causes the body’s immune response to fight against normal and cancerous B-cells.  Arzerra attaches to the small and large loop epitopes – on a molecule called CD20, which is found on the surface of B-cells, the type of cell which becomes cancerous in CLL.

The approval of Arzerra was supported by a positive recommendation by the FDA’s Oncologic Drugs Advisory Committee (ODAC) at ASCO on May 29, 2009, in which the panel voted, 10-3, that the data for ARZERRA were likely to predict clinical benefit for patients with CLL whose disease is refractory to fludarabine and alemtuzumab.

CERVARIX
The U.S. Food and Drug Administration (FDA)  has approved CERVARIX® [Human papillomavirus bivalent (types 16 and 18) vaccine, recombinant] for the prevention of cervical pre-cancers and cervical cancer associated with oncogenic human papillomavirus (HPV) types 16 and 18 for use in girls and young women (aged 10-25).

CERVARIX was shown to be 93 percent efficacious in the prevention of cervical pre-cancers (cervical intraepithelial neoplasia 2+/ CIN 2+ or adenocarcinoma in situ) associated with HPV 16 or 18, in women without evidence of current infection with, or prior exposure to, the same HPV type at the time of vaccination.  The majority (approximately 75 percent) of cervical cancers in North America are caused by HPV types 16 and 18.

SUMAVEL DOSEPRO
SUMAVEL DOSEPRO received FDA approval in July 2009 and is a first-of-its-kind needle-free delivery system for subcutaneous sumatriptan, a treatment that provides migraine relief within 10 minutes for some patients.

The DOSEPRO technology is an easy-to-use, pre-filled drug delivery system designed to enable self-administration of single doses of liquid drug formulations, subcutaneously, without a needle. The DosePro technology has undergone more than ten years of design, process engineering, clinical evaluation and development work. DosePro is protected by more than 80 patents, issued and applied for, worldwide. Approximately 9,000 injections have been delivered in clinical trials in healthy volunteers using the DosePro needle-free drug delivery system.

VOTRIENT
VOTRIENT, a once-daily, oral medication, is an angiogenesis inhibitor which may help prevent the growth of new blood vessels, thereby blocking the growth of kidney cancer tumors that need blood vessels to survive.

The approval of VOTRIENT was supported by a unanimous decision by the FDA’s Oncology Drugs Advisory Committee (ODAC) that the benefit-to-risk profile for VOTRIENT is acceptable for patients with advanced kidney cancer. The ODAC reviewed data from a Phase III clinical trial showing that VOTRIENT reduced the risk of tumor progression or death by 54 percent compared to placebo, regardless of prior treatment.


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