The FDA has given its nod to the Fridley Company’s Arctic Front system, which makes use of a freezing technology.
According to the Medtronic, it got the approval of the FDA for using a device to treat an irregular beating of the heart's upper chambers that can result in a stroke.
Medtronic's Arctic Front system stops the condition called the paroxysmal atrial fibrillation by filling a catheter's balloon with a coolant, freezing and forming lesions in the cardiac tissue surrounding the heart's pulmonary vein.
The opposition against caffeinated alcoholic drinks got stronger after Massachusetts became the fifth state in the US to ban caffeine-laced alcoholic beverages. Though, prior to the ban, the drinks regulator in the state was planning to restrict the sale of the drinks, but after the announcement by the FDA regarding Four Loko, a ban was imposed on the sale of caffeinated alcoholic beverages in the state of Massachusetts.
On Wednesday, an advisory committee of the Food and Drug Administration approved GlaxoSmithKline’s experimental drug for lupus, a disease that affects 5 million people every year across the globe.
The panel voted by 13 to 2 in favour of endorsing Benlysta in the US market. But, there have been recommendations from the arthritis advisory committee for restrictions and stringent investigation after the introduction of the drug, but the FDA has not any obligation to abide by the suggestions.
The FDA’s move to include images of dead bodies and diseases related to smoking on the cigarette packets would not depict the health hazards related to the peril clearly, as believed by a leading tobacco expert.
Dr. David Hammond, Professor of health studies at the University of Waterloo in Canada said, “There is good reason for having graphically strong pictures as long as they depict the health effects truthfully". He added that the images that are hard-hitting and gruesome have proved preventing kids children from smoking, but those employed by the FDA are not dreadful enough.
The U. S. regulators have given approval to Avanir Pharmaceuticals Inc. to manufacture a drug that will be used to deal with uncontrolled laughing or crying in patients suffering from neurological disorder called pseudobulbar affect (PBA).
The regulators also gave approval to Forest Labs for manufacturing injectable antibiotic Teflaro for treating patients with pneumonia and bacterial skin infections, including methicillin-resistant Staphylococcus aureus (MRSA).
Woes for the Company, Arena Pharmaceuticals Inc. have continued to increase, after the US Food and Drug Administration refused to approve lorcaserin. The drug, lorcaserin has been labeled as a weight-loss drug by the manufacturers. However, the FDA has stated that the medicine posed possible health risks to the people consuming the drug.
On Friday the Food and Drug Administration (FDA) approved the use of Botox as migraine treatment for those experiencing 15 or more days of migraine headaches per month. The injection, originally used as a wrinkle-smoothing injection, could add upwards of $600 million to annual revenues. As migraine treatment, Botox is expected to be worth $1 billion for Allergan Inc. within five years.
Approval for Botox as treatment for overactive bladders could come in late 2011 or 2012, adding another $500 million in revenue.
On Monday, the Company’s shares rose by $3.01, or 4.4%, to $71.87.
Botox injections have finally been approved by the Federal health authorities. These injections are believed to prevent chronic migraines in adults.
People, who are likely to have headache symptoms in the near future, can get Botox injected every three months around the head and neck. This would lessen the risk to a great extent, the Food and Drug Administration asserts.
A statement was released by the Federal health authorities, which suggests that this drug has little or no effect on other forms of headache. The generic name for this drug is onabotulinumtoxinA.
The government has warned the parents that the soft fabric sleep positioners could be dangerous for the baby and it could be even deadly for the little babies. The sleep positioners are used by the parents to keep the babies sleeping safely on their back. After finding 12 deaths because of the sleep positioners the Food and Drug Administration (FDA) and the Consumer Product Safety Commission has said the positioners are not safe for the babies totally and the parents should not use it because of a suffocation risk.
The U. S. Food and Drug Administration has asked Teva Pharmaceuticals for further details regarding the drug based on Amgen Inc.’s medicine Neupogen. Following the disclosure of details to the FDA, the drug would be approved.
The Israeli Company, Teva had earlier requested the FD to allow it to introduce its drug for patients suffering from severe neutropenia or a deficiency of white blood cells die to cancer. The Company would be introducing the medications under the name of Neutroval.
Baby sleep positioners were made to prevent the babies from rolling onto their stomachs. But they are now considered to be ‘dangerous nursery products’.
The Federal Regulators say that these products can be very harmful for kids. The infants can get trapped and die of suffocation. The regulators are demanding that the manufacturers should stop making them and the retailers should stop selling the product.
The Food and Drug Administration (FDA) has warned the makers of three products that they can’t claim the products are effective in preventing gum disease and removing plaque as no such benefit has been proven yet by use of the products.
The FDA has warned the three companies to stop mouthwash claims to promote their products. The claims from the company suggests that the product which are used by millions of Americans everyday are effective in preventing gum disease but no such remarkable benefit has been seen yet according to FDA.