FDA

FDA Panel Concerned Over Novartis’ MS Drug Safety

FDA Panel Concerned Over Novartis’ MS Drug Safety

A Food and Drug Administration panel announced a unanimous decision on Thursday concerning the cited potential side effects of proposed Novartis AG's multiple sclerosis drugs. It claimed that the multiple sclerosis pills were safe and effective. If approved, the drug would be the first pill to treat MS.

However, the major limitation related to this drug is the insufficient data in patients with pre-existing conditions who would be rendered at high risk for developing eye and cardiovascular complications, one reviewer highlighted.

French Pharma Seek Approval for New Contraceptive Pill

French Pharma Seek Approval for New Contraceptive Pill

A French drug manufacturing company is reported to have filed for permission to retail its pill that works long after "the morning after" for women in the U.S. The drug, retailed under the name ella, would be sold as a contraceptive.

Ella can be used to prevent pregnancy for up to 5 days or 120 hours after a woman has unprotected sex compared to the currently available pill in U.S. that is effective for the first 72 hours.

Approved in Europe last year, ella is used as an emergency contraceptive in 22 countries worldwide.

Genetic Testing to be Monitored by FDA

Genetic Testing to be Monitored by FDA

To confirm the validity of products, the Food and Drug Administration has ordered five Companies that proffer genome-sequencing tests to customers to offer scientific services for them. The tests that scan a person's DNA for gene variants linked with unambiguous diseases are medical devices entailing the agency's consent.

The California Company Navigenics proposes an analysis that offers information about how well the anticoagulant drugs warfarin and clopidogrel may function.

Glaxo’s Avandia Increases Heart Risks

Glaxo’s Avandia Increases Heart Risks

An US Food and Drug Administration (FDA) reviewer who worked on the study said government scients had analysed Avandia, GlaxoSmithKline Plc’s controversial diabetes drug and found it to increase heart risks, including deaths compared to a rival pill.

Known for opposing now-withdrawn painkiller Vioxx, Dr. David Graham and other government staff reviewed data on Medicare health insurance programme for the elderly patients taking Avandia or competitor Actos (Takeda Pharmaceutical Co Ltd.)

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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