FDA

Genetech's New Arthritis Drug Gains FDA Approval

Genetech's New Arthritis Drug

Confirmation has been received that the US Food and Drug Administration has approved a new class of drug for rheumatoid arthritis created by South San Francisco's Genentech.

Called Actemra, the medicine is the first arthritis treatment which would operate by blocking the activity of interleukin-6, a protein which, when overly abundant in the human body, leads to inflammation in the joints which is strongly linked to arthritis.

The drug was approved by the FDA on Friday.

Seroquel XR for Use in Depression Approved by FDA

The US Food and Drug Administration has approved AstraZeneca's drug Seroquel XR for use in adult patients suffering from depression, albeit in small numbers and only if all other treatment drugs have failed to trigger a response, as confirmed by the pharmaceutical company. The agency, however, wants more information and some more tests before it can approve the medicine as a "first-line treatment".

FDA Shared Preliminary Review of Diet Drug Meridia based on Study

Weightloss Pill Meridia FDA

The US Food and Drug Administration is currently in the process of reviewing a new diet drug Meridia, and while a final stance is still awaited, the agency has revealed preliminary data on the drug, according to which certain patients indulging in the long term use of the drug could be exposing themselves to an increased risk of heart attacks, strokes and come other serious cardiovascular problems. The revelation is based on findings put forward by a new study.

Qutenza Patch for Lingering Shingles Pain Gains FDA Approval

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A new treatment for postherpetic neuralgia (PHN), a pain which tends to linger after a shingles attack, called the Qutenza has been awarded approval by the US Food and Drug Administration. Offering treatment via placement of a patch, the new drug is being marketed by San Mateo, California based NeurogesX.

Qutenza Patch to Treat Pain Wins FDA Approval

Qutenza Patch to Treat Pain Wins FDA Approval

The US Food and Drug Administration has successfully approved NeurogesX Inc's Qutenza patch, which has been developed to relieve shingles-related pain.

To treat post herpetic neuralgia, or nerve pain, successfully, the patch uses synthetic capsaicin in very high concentrated doses.

Approval of Genzyme's Lumizyme on Hold, FDA Seeks Explanation of Manufacturing Deficiencies First

Approval of Genzyme's Lumizyme on Hold, FDA Seeks Explanation of Manufacturing D

The US Food and Drug Administration is holding its review and approval of drug-maker Genzyme's new medicine to treat Pompe disease, a rare muscle disorder, till the company looks into and explains the manufacturing deficiencies found in its two popular drugs which are made at the Allston Landing plant in Boston, as was confirmed by Genzyme on Monday.

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