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Shining Light on Cervical Cancer

The US Food and Drug Administration (FDA) has recently approved the MediSpectra, Inc, cervical imaging system (Luma) for use in conjunction with colposcopy to reduce the number of cancer-risk precursors overlooked during evaluation for abnormal Papanicolaou tests. More efficient at detection than colposcopy alone, cervical imaging takes only 12 seconds to perform and results are available immediately. The cervical imaging system uses a combination of fluorescence spectroscopy, white light diffuse reflectance spectroscopy, and video imaging to scan cervical tissue and aid in the early detection of high-grade cervical cancer precursors.

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A New Choice in Oral Contraception

As of April 2006, another oral contraceptive (OC) is available from Berlex, Inc. The FDA has approved the company’s new low-dose monophasic OC containing ethinyl estradiol (EE) and drospirenone (DRSP) (Yaz). Unlike traditional OCs that are taken for 21 days followed by 7 days of placebo, this combination of EE 20 mcg and DRSP 3 mg allows for 24 days of active pill and 4 days of placebo. This OC formulation contains lower doses of estrogen compared to traditional OCs, and has a shorter pill-free interval, which in turn results in less hormonal fluctuation between cycles and provides other noncontraceptive benefits such as antiandrogenic effects.

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Getting Rid of Heartburn

The FDA has approved a new treatment for heartburn, gastroesophageal reflux disease, erosive esophagitis, and duodenal and gastric ulcers. Santarus, Inc, has received approval for its immediate-release proton pump inhibitor (PPI) containing omeprazole, sodium bicarbonate, and magnesium hydroxide (Zegerid). The drug is administered in capsule, powder for oral suspension, and chewable tablet forms. Instead of the enteric coating used in other PPIs, Santarus’s product utilizes antacids to protect omeprazole from gastric acid degradation; this allows for rapid absorption of the drug and suppression of gastric acid.

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Multipotent Mitoxantrone

The FDA has granted final approval to Mayne Pharma’s abbreviated new drug application for mitoxantrone. The parenteral drug is generically equivalent to Serono, Inc's, mitoxantrone injection (Novantrone). The antineoplastic drug is used to treat some forms of cancer by interfering with the growth of cancer cells. The drug is also used to extend the time between relapses in some forms of multiple sclerosis.

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Relief for Head and Neck Cancer

Cetuximab (Erbitux), approved in 2004 for the treatment of colorectal cancer, has now been cleared to treat cancers of the head and neck. A study has found that the drug, in conjunction with radiation, increased the survival rate of head and neck cancer patients by 20 months, compared to treatment with radiation alone. Cetuximab is effective in the treatment of surgically inoperable squamous cell cancer of the head and neck, as well as the treatment of patients in whom chemotherapy has failed. With approximately 29,000 US citizens diagnosed with cancer of the head and neck each year, and no new therapies since the 1950s, the product addresses a need for new treatments.

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