FDA

Approved drug to also cover anal cancer

The purview of the approval given by U. S. Food and Drug Administration to Gardasil (human papillomavirus vaccine) has been broadened to also comprise of anal cancer and other similarly linked precancerous lesions, as reported by the agency said in a news release.

Human papillomavirus (HPV) is linked to approximately 90% of the estimated 5,300 cases of anal cancer tested in the US every year, according to the FDA, which cited figures from the records of the American Cancer Society. More number of women tested positive than that of men.

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FDA Not in Favor of Approving MelaFind

Following criticism from the Food and Drug Administration for a device used for skin cancer detection device from MELA Sciences Inc, a panel of Government health experts are said to have voted in favor of the device intently.

An agency spokesman said that the panel had voted 8-7 with one abstention since it had been made very clear that the overall gains of the Company's hand-held MelaFind device happened to outweigh its risks.

This new device is said to have been designed to assist dermatologists spot cancerous skin moles with the help of computer imaging technology.

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FDA Approves Xgeva for the Prevention of Fractures in Bone Cancer Patients

In an attempt to avert fractures and other skeletal complications for the people suffering from advanced cancer which has spread to the bones, the U. S. Food and Drug Administration has finally approved Xgeva (denosumab).

Xgeva's manufacturer, Amgen Inc said that around 75% of the people suffering from advanced cancer of the prostate, lung or breast, have high chances of it spreading to their bones.

Furthermore there is a very high probability of it leading to complications such as debilitating pain, bone fractures and compression of the spinal cord.

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FDA Calls off Prescription Painkiller from Market

A painkiller prospective of bearing risk of inflicting deadly heart problems has been called off from the market on Friday at the request of federal regulators.

After the calls from the Food and Drug Administration, Xanodyne Pharmaceuticals of Newport, the manufacturer of the drug Darvon consented to pull off the drug from the market. The FDA's calls also apply to the Companies, which make versions of the drug called propoxyphene.

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Indian Pharmaceutical Sees Generic Drugs Approved by FDA

On Thursday, Mumbai-based Sun Pharmaceutical Industries announced that it received approval from the US Food and Drug Administration to market generic versions of Clarinex tablets and Tiazac capsules. The FDA approval will allow Sun Pharmaceuticals to market the generic drugs in the US.

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