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Tag: "fda" at medical news

NEW ROBOTIC SURGERY ARM APPROVED BY FDA

FDA today cleared for marketing a robotic device that enables a surgeon to perform laparoscopic gall bladder and reflux disease surgery while seated at a console with a computer and video monitor. The surgeon can use hand grips and foot pedals on the console to control three robotic arms that can perform the surgery using a variety of surgical tools. The product, the Da Vinci Surgical System, mad...

Abortion Pill approved by FDA

Mifepristone (known as RU-486 in Europe) has been around for over a decade and used by European women as an alternative to surgical abortion in early pregnancy. It has now been approved by FDA for sale in the USA. It will be avilable as Mifeprex... ..Gloria Feldt, president of Planned Parenthood Inc said,"Mifepristone, or the early-abortion pill, is as..significant a technological advance for wom...

Another injectable contraceptive Pill approved by FDA

Lunelle-a monthly injectable contraceptive pill has been approved by the Food and Drug Administration in USA... ..It is more than 99 percent effective when women get the shot once every month according to the company release marketing the pill... ..Lunelle is an alternative to another injectable contraceptive called Depo-Provera that lasts three months. It works Like many other birth control pill...

New FDA Approved Drug To Treat Migraine

Axert has been approved by the FDA for the acute treatment of migraine with or without aura in adults. ....This drug targets serotonin receptors and act against migraine headaches by inducing the constriction of blood vessels surrounding the brain. ....Nausea, sleepiness, numbness, dry mouth and headache are the side effects associated with the use of Axert. In controlled trials, Axert showed a...

Lose Weight With New Wonder Slimming FDA approved Prescription Drug

There is a new wonder slimming FDA approved drug which can actually works. Not only that - it even lets you eat normally, all while you are slimming. This wonder slimming drug is XENICAL. ....Xenical allows about 30% of the fat eaten in a meal // to pass through the gut undigested. Your body cannot convert these excess calories to fatty tissue or use them as a source of energy. This will therfor...

New FDA Approved Drug NATRECOR For Heart Failure Patients

The US government has approved a genetically engineered drug called NATRECOR to ease the breathing of hospitalized congestive heart failure patients. .. Congestive heart failure is a condition // in which the heart can't pump enough blood to meet the needs of the body's other organs. Most of the patients with congestive heart failure suffer flare-ups in which they gasp for breath and need hospita...

Novartis files application with FDA for Zometa

Novartis Pharmaceuticals has submitted an application to the Food and Drug Administration, seeking marketing authorization for Zometa in the treatment of bone complications associated with a broad range of tumor types. These include prostate and lung cancer, for which no bisphosphonate therapy is currently approved. The spread of cancerous cells from the original tumor to the bone, can lead to se...

FDA's control is inherently weak

The Food and Drug Administration has few details about the dramatic rise in overseas drug testing and reforms are needed to protect both foreign patients taking experimental medicines and Americans who buy products based on their results. ....The number of pharmaceutical researchers working outside the United States who voluntarily report their experiments to the FDA increased 16-fold from 1990 t...

FDA Approves Contraceptive Ring

The U.S. Food and Drug Administration has approved the first hormone-releasing contraceptive implant. NuvaRing, sold by Organon, Inc., effectively blocks conception between 98 percent and 99 percent of the time -- meaning that for every 100 women who use it for a year, only one or two will become pregnant, the FDA says. That rate is similar to both the birth control pill and the yet-unapproved co...

FDA approves new device to treat women's bleeding disorder

The government has approved a new method to treat women suffering excessive menstrual bleeding, a device that uses radio waves to zap the tissue at fault. Millions of women suffer menorrhagia, benign but troubling menstrual bleeding so excessive they can require more than 20 tampons in a single day. Thousands of women every year get hysterectomies to cure menorrhagia, while other women try hormon...

Ranbaxy gets US FDA approval for Lisinopril

Ranbaxy Pharmaceuticals Inc (RPI) has received a tentative approval from the US FDA for Lisinopril tablets. Lisinopril is recommended for hypertension, either alone for initial therapy or with other classes of anti-hypertenive agents. It is also used as adjunctive therapy in the management of heart failure and patients who do not respond to diuretics. // ....However it expects to launch the pr...

FDA Approves New HIV Drug, Viread

Biopharmaceutical firm Gilead Sciences Inc. said it has received approval from the US Food and Drug Administration (FDA) to market its antiretroviral agent Viread (tenofovir disoproxil fumarate) for the treatment of HIV in combination with other antiretroviral agents. ....Like Viread, such drugs work by blocking the process needed for HIV replication in the body. But Viread is the first nucleotid...

FDA Approves Birth Control Skin Patch

For the first time, the US Food and Drug Administration (FDA) has approved a contraceptive skin patch for weekly use. Ortho Evra, made by New Jersey-based Johnson & Johnson, is a one-and-three-quarter-inch patch containing the hormones norelgestromin and ethinyl estradiol, designed to be an alternative to birth control pills. // ....The patch delivers the hormones through the skin for a 1-week p...

FDA approves surgical gel

The Food and Drug Administration (FDA) approved a gel that promises less internal scarring for women undergoing certain surgeries. The FDA had initially rejected Lifecore Biomedical Inc.'s Intergel, which promises to reduce internal scarring from certain gynecologic operations. // ....The gel, formally named Gynecare Intergel Adhesion Prevention Solution, is intended to reduce adhesions, interna...

FDA Approves New Arthritis Drug, Bextra

The US Food and Drug Administration has approved a new drug for treating osteoarthritis. Osteoarthritis is a progressive deterioration in the cartilage of certain joints. Unlike rheumatoid arthritis, which is an inherited autoimmune disease, osteoarthritis results from overuse of joints, and can be a byproduct of strenuous sports, obesity or aging. ....Pharmacia Corp. makes the drug, Bextra (vald...

FDA attacks American Red Cross for blood violations

The Food and Drug Administrations asked a federal judge to hold the American Red Cross in contempt of court for repeated safety violations in its blood collection program. FDA is acting today to ensure that the Red Cross takes much more seriously its role as guardian of the safety of the nation's blood supply, which is essential to the public health. // ....Despite a promise made by the Red Cros...

FDA issues warning for Droperidol

A drug commonly used by anesthesiologists can cause fatal irregular heartbeats at lower doses than expected, prompting the government to urge doctors to try different medications. At issue is droperidol, a tranquilizer often used to treat the nausea many people feel after undergoing anesthesia. ....Droperidol has long carried a warning that it could cause sudden cardiac death at high doses in pa...

Morepan to file new drug applications with the USFDA

Domestic pharma major Morepen Labs is planning to file its nine abbreviated new drug applications (ANDA) with the US FDA by the year 2003. The company would file its first two ANDAs - Loratadine (anthistatminic drug) and Atorvastain Calcium (anti-cholesterol) - by the end of 2002. Loratadine is the third-largest selling drug in the world. ....Currently, Morepen’s ANDAs pipeline has Loratadine, Fe...

FDA Approves Elidel Cream for Eczema

The FDA announced it had approved Elidel ( pimecrolimus ) cream for treating mild to moderate forms of the skin condition called atopic dermatitis, or eczema. The skin condition is common, causing red, swollen, and itchy rashes that often seep and ooze. The drug maker, Novartis, notes more than 40 million people in the U.S. develop flare-ups of eczema. // ....It is a prescription cream for the s...

FDA approves drug for rare liver disease

Hereditary tyrosinemia type 1( HT-1) is a genetic metabolic disorder that causes progressive liver failure and liver cancer in young children. It's a very rare disease.// It is not among the metabolic diseases that all newborns are tested for at birth, so often infants die undiagnosed. This is an absolutely fatal disease until now. ....Children born with such a very rare but very lethal liver dis...

FDA approves first pocket-sized EKG machine

The government approved the first pocket-sized EKG machine, so small that it promises easier, faster heart measurements in ambulances, the emergency room - even a possible heart attack victim's bedroom. It's also the first hand-held computer-based medical device, part of a growing trend to miniaturize some of medicine's most important equipment. ....Electrocardiograms, also called EKGs or ECGs, a...

FDA Imposes New Restrictions On Roche's Accutane

Women taking Roche Inc's popular acne treatment Accutane (isotretinoin) will soon have to submit to new restrictions aimed at preventing unwanted pregnancies while on the drug. The US Food and Drug Administration (FDA) said that it has approved significant changes to the drugmaker's pregnancy prevention programme. The pregnancy prevention programme was adopted about 13 years ago, when Accutane wa...

Northfield Labs Receives FDA Comments

Northfield Laboratories, founded in 1985, is a leading developer of an oxygen-carrying blood substitute. Its product, PolyHeme, is the only blood substitute undergoing clinical trials that has been tested at large enough dosages to be considered a substitute for acute blood loss in trauma and surgical settings. As a result of the process used to manufacture the blood substitute, essentially a sol...

FDA Approves New Anti-Clotting Drug

The Food and Drug Administration (FDA) announced the approval of Arixtra (fondaparinux sodium) Injection for reducing the risk of blood clots after orthopedic surgery for hip fracture, hip replacement, and knee replacement. Arixtra is the first synthetic anticoagulant indicated for use in these types of surgeries.// ....The formation of clots in the deep veins of the legs is common after these su...

FDA debates status of decongestant drugs

An advisory committee for the Food and Drug Administration agreed that an ingredient commonly used in over-the-counter decongestants is unsafe, and it plans to recommend further review by the FDA. ....The FDA Non-Prescription Drugs Advisory Committee met to discuss a new five-year study by Yale University researchers that found phenyl-propanolamine (PPA), an active ingredient in non-prescription...

FDA fish warning criticized

The Food and Drug Administration recommends pregnant women to avoid swordfish, shark, king mackerel, tilefish, tuna steaks, sea bass, Gulf Coast oysters, marlin, halibut, pike, walleye, white croaker, and largemouth bass. The Environmental Working Group (EWG) recommends pregnant women and young children to eat only small amounts of fresh-caught fish once a week. Under industry pressure, the Food...

FDA Approves New surgery Treatment for Farsightedness

The US Food and Drug Administration has approved a new treatment for farsightedness known as conductive keratoplasty. The technique uses radiofrequency energy to// shrink small areas of the cornea, the transparent coat on the surface of the eyeball. Unlike laser in situ keratomileusis (LASIK), in which the surface of the eye is reshaped using a laser, conductive keratoplasty does not require cutt...

Plavix Gets FDA Okay for New Indication

The antiplatelet medication Plavix (clopidogrel bisulfate) received US Food and Drug Administration approval for use in acute coronary syndrome. People with acute coronary syndrome are at high risk for heart attack, typically because they have unstable angina, or heart disease-related chest pain. About 1.1 to 1.4 million Americans experience acute coronary syndrome each year.// ....Plavix was fi...

FDA may speed review of new drugs

The Food and Drug Administration has reached agreement with the drug companies it regulates on steps that might speed review of new medications, in return for tens of millions in new industry fees. ....The industry has long funded a significant portion of the FDA’s drug review work. But for the first time, the agreement would allow some of that money to go to improved safety monitoring of new dru...

FDA Approves Anti-Cancer Cell Drug - Zevalin

The government approved a long-awaited treatment for lymphoma - a drug that uses a novel approach to bring radiation directly to cancer cells. Idec Pharmaceuticals' Zevalin becomes the first radioimmunotherapy drug cleared to sell in the US. // ....It's a new approach, adding radiation to antibodies that search out a protein called CD20 found on lymphoma cells. The antibodies attach to the cells...

FDA considers nicotine lollipops illegal

The Food and Drug Administration cracked down on Internet distributors of nicotine-laced lollipops and lip balm, declaring them illegal and ordering that 4 pharmacies stop sales immediately. The lollipops in particular pose a risk to children because they look like regular candy, the FDA warned. "The quantity of nicotine could be potentially dangerous to a small child," said FDA attorney David Ho...

FDA panel refuses anti-viral cold remedy

An advisory panel voted unanimously against recommending FDA approval for the first antiviral cold medication, dashing company hopes of having the drug on the market in time for this year's cold season. The FDA's Antiviral Drugs Advisory Committee cited safety concerns of the drug pleconaril, which it said were not balanced by the drug's "modest" benefits in treating an illness that is not life-t...

FDA changes rules on testing drugs for children

The FDA is suspending a rule that lets the government require safety testing of adult medicines commonly given to children, a move that has drawn the ire of some Democratic lawmakers. FDA says Congress recently reauthorized financial incentives for manufacturers to do those studies. The FDA said it wants to see if the new law makes the old mandate, which drug makers hated, unnecessary.// ....But...

FDA approves Phase 0 trial which tests experimental drugs on humans

Good news for researchers has FDA has approved testing of small quantities of experimental drugs in human beings. Approval of small quantity drug clinical trial will be very helpful for researchers to// understand the path of the drug in the body and its efficacy if the drug is proved effective in small quantities researchers can proceed with a phase I clinical trial. ..Researchers feel that e...

FDA Approves Remodulin for Pulmonary Hypertension

According to a notice distributed by the agency, the US Food and Drug Administration (FDA) has approved United Therapeutics Corp.'s pulmonary arterial hypertension therapy Remodulin (treprostinil sodium). A spokesperson for the FDA told Reuters Health that the approved indication covers NYHA class II-IV pulmonary arterial hypertension. The FDA approved the drug under subpart H, which allows for m...

New FDA regulations puts some cough syrups off market

The Food and Drug Administration's(FDA) new effort to re-examine very old drugs that began selling before the government ever required proof that drugs worked well, has landed dozens of brands of prescription cough syrup in trouble. Until now FDA stressed that the expectorant, extended-release guaifenesin, is not dangerous. However, the recent crackdown lead to the FDA formally approving sale of...

FDA approves Watson Pharmaceuticals' Oxytrol patch

The Food and Drug Administration has approved a new patch developed by Watson Pharmaceuticals Inc., for the treatment of an overactive bladder. The patch called Oxytrol (generic: oxybutynin transdermal system) reduces urinary urge incontinence, urinary urgency, and urinary frequency, according to the drug's maker. Oral forms of oxybutynin has been around for around 25 years but it has not been po...

FDA Approves New Osteoporosis Drug

There is good news for women suffering from postmenopausal osteoporosis. The Food and Drug Administration of America // has approved a new drug Boniva (ibandronate sodium) manufactured by GlaxoSmithKline and Roche for people suffering from osteoporosis. The drug to be taken monthly under the advice from the physician will help in bone building, even if its results may not be felt directly. ....Os...

FDA Approves New Drug For Asthma In Children

FDA has approved a new inhaler therapy for children with asthma called Asmanex Twisthaler 220 mcg to be taken only once daily// . ....The oral inhalation treatment may take about 1 to 2 weeks or longer after starting the treatment for the maximum effect to take place. The medication provides topical effect to systematic activity in extensive hepatic metabolism. A maintenance treatment for asthma...

FDA to bring about changes in Marketed Non-Steroidal Anti-Inflammatory Drugs

American drug market watchdog Food and Drug Administration had announced a series of changes to be followed for// the drugs in the class of non-steroidal anti-inflammatory drugs that are sold with or without prescription over the counter. These changes include the withdrawal of the drug Bextra (valdecoxib) from Pfizer, Inc. ....Pfizer, Inc was asked to withdraw the drug Bextra as FDA had reports...