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Tag: "approval" at medical news

Abortion Pill approved by FDA

...many women, that is a very positive thing." "The approval of mifepristone is the result of the FDA's careful...missioner of food and drugs. "The FDA's review and approval of this drug hasadhered strictly to our legal mandate and mission as a science-based public health r...

New FDA Approved Drug NATRECOR For Heart Failure Patients

...blood pressure. Two years ago, the FDA rejected approval of Natrecor because it caused so many cases of hypotension rates of 8 percent to 14 percent, depending on the dose used. Hence studies were conducted in another study group of 498 patients with a much smaller dose. This time, low blood pressure struc...

Ranbaxy joins hand with Cipla to co-market ciprofloxacin

...eceived Drug Controller General of India’s (DCGIs) approval for marketing in India. Ciproloxacin is a unique dosage form of the broad-spectrum antibiotic. The domestic market for ciprofloxacin is estimated to be around Rs 310 crore. //Ciprofloxacin is the most potent fluoroquinolone with the widest spectrum...

Surgeons implant second artificial heart

...rer of the heart has been given initial regulatory approval for testing of the device on five critically ill patients....

Pharma majors gear to supply anti-anthrax drug

...es with the U.S. Food and Drug Administration(FDA) approval for the manufacture of Ciprofloxacin. The Mumbai-based Cipla, which is also approved by the U.S. FDA, has also offered to supply large quantities of Ciprofloxacin, the active ingredient of Cipro to a generic producer in the U.S. Ciprofloxacin is a ...

Ranbaxy gets US FDA approval for Lisinopril

...Pharmaceuticals Inc (RPI) has received a tentative approval from the US FDA for Lisinopril tablets. Lisinopril...l alone sold $ 0.66 billion in 2000. The tentative approval has been given for a single entity form of Lisinopril. An Abbreviated New Drug Application (ANDA) su...

Ajanta Launches World's First Once-A-Day Nimesulide Oral Formulation

...n Mumbai. // Since the brand received marketing approval from the Drug Controller General of India last month, it has been manufactured at Ajanta's Aurangabad factory. Nimlodi is marketed under the Ethicare division of Ajanta and the Company has already filed a patent application for the product. Nimlodi b...

FDA Approves New HIV Drug, Viread

...cal 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 n...

New Drug, Pleconaril speeds recovery from common cold

...ny applied to the Food and Drug Administration for approval to market the drug. The company has not said how much it will charge for the medicine, which would be sold by prescription under the brand name Picovir, but officials said it is likely to cost as much as antibiotics....

Laser to help in root canal treatment

...oot canal procedures on hard and soft tissue.//The approval is the first by the FDA for a laser root canal and covers all enamel, dentin and pulpal removal as well as shaping of the root canal. The Waterlase is not a direct laser, the but alternatively furnishes optical energy to water, and the water particl...

FDA Approves New Anti-Clotting Drug

...e 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 surgeri...

New pacemaker reduces risk of heart failure

...nted in more than 3,000 people in the US since its approval by the FDA. It is intended for people with a particular form of heart failure, a debilitating illness in which people suffer shortness of breath because their hearts do not beat strongly enough. Overall, an estimated 5 million Americans have heart ...

Heart Drug has grave side effects

...r term, unlike the research that led to government approval of the drug. The study involved 949 patients given either a dummy drug or a 48-hour milrinone infusion....

Drug Offers Hope for Alzheimer's disease

...cade in Germany// and was recently recommended for approval by the European Union's equivalent of the Food and...ufacturer of the drug, is expected to file for FDA approval sometime this year. The company is also exploring uses for the drug in earlier stages of the disease...

Plavix Gets FDA Okay for New Indication

...isulfate) received US Food and Drug Administration approval for use in acute coronary syndrome. People with ac... usually given in addition to aspirin. To get FDA approval for acute coronary syndrome, Bristol-Myers submitted data from a trial that was published in The New...

FDA panel refuses anti-viral cold remedy

...y 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 bal...

Smoking may be influenced by Parents

...the match to light a cigarette, he is giving tacit approval and even encouragement for the child to smoke as well. We need to establish programs that bring this to parents' attention so they can curb this behavior. Researchers gave a group of seventh and eighth graders in San Diego a questionnaire that asked...

Canine Painkiller unveiled by Novartis

Novartis received approval from the Food and Drug Administration to begin marketing Deramaxx, a canine painkiller, which will be used to relieve post-operative pain in dogs. This drug being produced by a Novartis facility at Puerto Rico //is the result of a development project...

Animal insulin product to be discontinued by drug major Eli Lilly

...t and that the company is awaiting the governments approval for the phase II and III trials for this inhaled version. However, he added that the drug will cost more due to higher dose requirements compared to the injectible form and will be available only five years down the line....

Lamictal as add-on therapy for children with epilepsy

...e or jerking movements of certain body parts. The approval of the drug was based on a clinical study that demonstrated the efficacy of the drug as add-on therapy in pediatric patients who were still having frequent partial seizures (at least four per month) despite optimal doses of other anti-epilepsy drugs ...

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