Approves

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...

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-unapp...

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 tr...

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 nu...

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...

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,...

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, Bextr...

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 fo...

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 li...

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...

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 t...

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 requ...

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 th...

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 allo...

World Health Organisation Takes a Historic Decision and Approves Treaty to Discourage Smoking

The 192 members of WHO unanimously adopted the Framework Convention on Tobacco Control (FCTC) aimed at curbing tobacco-related deaths and disease on 22nd May 2003. The Convention requires countries to impose restrictions on tobacco advertising, sponsorship and promotion, establish new labelling and clean indoor air controls and strengthen legislation to clamp down on tobacco smuggling.//...

World Health Organisation Takes a Historic Decision and Approves Treaty to Discourage Smoking

The 192 members of WHO unanimously adopted the Framework Convention on Tobacco Control (FCTC) aimed at curbing tobacco-related deaths and disease on 22nd May 2003. The Convention requires countries to impose restrictions on tobacco advertising, sponsorship and promotion, establish new labelling and clean indoor air controls and strengthen legislation to clamp down on tobacco smuggling.//...

World Health Organisation Takes a Historic Decision and Approves Treaty to Discourage Smoking

The 192 members of WHO unanimously adopted the Framework Convention on Tobacco Control (FCTC) aimed at curbing tobacco-related deaths and disease on 22nd May 2003. The Convention requires countries to impose restrictions on tobacco advertising, sponsorship and promotion, establish new labelling and clean indoor air controls and strengthen legislation to clamp down on tobacco smuggling.//...

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...

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...

FDA Approves Indian Generic Drug For AIDS Treatment

FDA has approved the first generic version of the AIDS drug Retrovir (AZT). This generic drug// is manufactured by Ranbaxy Laboratories. Due to patent laws it will not be able to market this anti-retroviral drug in US, but it will be available for patients in the developing countries, it will be made available for purchase and use abroad under the president’s emergency plan for AIDS Relie...

Indian Health Ministry approves sale of Emergency contraceptives as over the counter drug

Emergency contraceptives will be available in pharmacies as over the counter drug with out medical prescription in India, which will enable women to avoid unnecessary pregnancy. The decision was announced// by the Indian Health minister Anbumani Ramadoss, on informing the governments decision the minister said, "The step has been taken to enable women to avoid pregnancy in such situations...

Madras High Court Disapproves of Comparative Advertisements

The Madras High Court in India has called for curtailing comparative advertisements, after reviewing applications from two health food producers//. Suitable amendments should be made to the Code for Commercial Advertising on Doordarshan, in addition to other media and channels, and the Monopolies and Restrictive Trade Practices Act in the country. There is a blanket ban in some wester...

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...

FDA Approves Novel Creation of Imitrex? Injection for Migraine

The Food and Drug Administration (FDA) has approved a creation of the Imitrex Injection that enables patients to consume a 4mg dosage, // named as the Imitrex STAT dose System ? used to treat severe migraines in adults in the presence or absence of aura. Migraine is known to be a common ailment for as many as 28 million Americans suffers from migraine headaches. The treatments for mi...

FDA approves CLARINEX-D 12 HOUR for seasonal allergic rhinitis

Food and Drug Association as approved the drug CLARINEX-D 12 HOUR for use in treating symptoms of seasonal allergic rhinitis. // CLARINEX-D 12 HOUR is a drug containing a combination of desloratadine 2.5 mg and pseudoephedrine sulfate, USP 120 mg. FDA has approved the drug for use in persons above 12 years of age. The drug has been found effective in curing persons with nasal and non-n...

Britain Approves Indian Company For Supplying Medicines

Britain gave the green signal for the Chennai-based Shasun Chemicals and Drugs Ltd on Wednesday for supplying medicines that would soon hit the European markets soon. // With the approval from the British Medicines and Healthcare products Regulatory Agency (MHRA), Shasun's products from its formulation facility in Pondicherry can now be sold in Britain and other European countries. <...

US Senate Approves Embryo-research Plan Despite President's Refusal

The US Senate voted to expand federal funding for research on new human embryonic stem cells, setting the stage for George W. Bush's first veto of his presidency.// The 63-37 vote followed two days of debate that pitted the promise of new disease cures against deep questions of conscience, especially among Bush's supporters on the religious right who view embryos as human life and opp...

FDA Approves New Test For Screening Infection In Babies

A new test that screens babies for the presence of a common infection was approved by the Food and Drug Administration on Tuesday. Group B streptococcus// is a common infection that is passed from mother to child. It can cause sepsis, pneumonia, meningitis, neurological damage or even death. Although all women are tested for group B streptococcus during pregnancy, current screening me...

FDA Approves Pfizer’s Anti-smoking Dru

Pfizer’s new drug, Chantix, which will help cigarette smokers to quit smoking, wins U.S. Food and Drug Administration’s approval//. The active ingredient in Chantix is varenicline tartrate. The FDA gave chantix priority review based on the better effectiveness shown in preliminary trials compared to another anti-smoking drug known as zyban. Drugs receiving priority review get approved...

India Approves Baraclude? (entecavir) For Treatment Of Chronic HEPATITIS B

Bristol-Myers Squibb has announced the launch of BARACLUDE? (entecavir) for the treatment of chronic hepatitis B virus infection //following its approval by the Drug Controller General of India. BARACLUDE (entecavir) is indicated for the treatment of chronic hepatitis B virus infection in adults with evidence of active viral replication and either evidence of persistent elevations in...

FDA Approves Famvir For Genital Herpes

The US Food and Drug Administration has approved a drug called Famvir as a one-day treatment for recurrent genital herpes and cold sores. //The drug is manufactured by Novartis Pharmaceuticals Corp and is intended to be taken by people with healthy immune systems. The drug can be consumed as 1,000 milligrams doses twice daily for one day. There is no cure for genital herpes and this drug...

NICE Approves The New Class Of Breast Cancer Drugs

A new class of breast cancer drugs had yesterday won the final draft of approval for use in the NHS alongside the ‘gold standard’ Tamoxifen.// The National Institute for Health and Clinical Excellence (Nice) had issued a final draft on the appraisal for the use of three types of aromatase inhibitors in postmenopausal women with early breast cancer. It was explained that these drugs wo...

US Approves the Sale of Morning after Pill Without Prescription

After years of emotional debate, US health authorities have approved the sale of the morning-after contraceptive pill without a prescription for women 18 years and older.// But girls under 18 will need a prescription from a physician, the Food and Drug Administration said Thursday. The medication, which contains a high dosage of hormones contained in birth control pills, i...

FDA Approves Vectibix for Colorectal Cancer

Vectibix, a drug meant for treating patients with advanced colorectal cancer has been approved for use in cases where the cancer has spread to other parts of the body.//Panitumamab, which is being marketed as Vectibix by Amgen Inc has been found to shrink tumor size and retard cancer cell growth. The approval has added to the available choices of treatment for a disease, which has a hi...

Study disapproves a new Asthma inhaler

A study assessing a new asthma inhaler revealed that it has problems. This investigation was conducted subsequent to the decision of PHARMAC in 2005 to stop// the funding for Ventolin inhalers in favour of Salamol. In the study, 36 asthmatics using the Salamol inhaler were observed. Only 15 of them were able to stick to the study. The rest withdrew either due to the ineffectiveness of t...

Senate Committee Approves Telemedicine Mental Health Bill

The Senate Indian Affairs Committee on Thursday approved by voice vote a bill that would authorize $6 million to provide mental health services for suicide// prevention, intervention and treatment available to American Indians and Alaska Natives through expanded telemedicine systems, CongressDaily reports. Under the legislation, sponsored by committee Chair Byron Dorgan (D-N.D.), five...

India Approves Oral Drug for Treating Kala-Azar

The Drug Controller General of India has recently approved oral anti Kala-azar drug “Miltefosine” for treatment of Kala-azar patients.// The clinical trials of Miltefosine – oral drug have been conducted by Indian Council of Medical Research, New Delhi. Based on the results of clinical trials, the Expert Committee of the Directorate of Health Services has recommended introduction of Mi...

FDA Approves Novel Test to Check Tainted Blood in Blood Banks

The Food and Drug Administration gave the go-ahead for a diagnostic test, to check for the presence// of a life-threatening parasitic infection, widespread in Latin America and the United States’ blood banks that could pose a huge risk to patients. Many reputed blood banks have seconded this move, and have agreed to induct the test soon, to check for the disease, technically termed as...

FDA Approves A New Pill For Treatment Of Acne

FDA has approved a new drug, named YAZ, which can be used as an oral contraceptive for birth control and also for treating acne.// The U.S. Food and Drug Administration have formulated this drug especially for woman, which can also treat emotional and physical symptoms of premenstrual dysphoric disorders. The YAZ drug, manufactured by Bayer Schering Pharma AG has become the fi...

FDA Approves New Product to Treat Von Willebrand Disease

The U.S. Food and Drug Administration (FDA) today announced the approval of Antihemophilic Factor/von Willebrand Factor Complex (Human), Alphanate. //The product is approved for patients undergoing surgery or invasive procedures with von Willebrand disease (vWD) in whom the hormone desmopressin is either ineffective or contraindicated. It is not approved for patients with severe vWD (Type...