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Tag: "submitted" at medical news

Drug regulatory officials giving the nod for sale of Unapproved drug formulations in India

... for use in adults, as illegal. The documents they submitted to the court indicated that dozens of unapproved formulations of nimesulide combined with various other drugs, such as analgesics, anti-allergy drugs, muscle relaxants, and other non-steroidal anti-inflammatory drugs, remain unapproved however are st...

Ankylosing spondylitis may not be detected in children

...the University of Toronto had looked into the data submitted by over 2000 patients suffering from ankylosing spondylitis. The results of the study show that late diagnosis along with childhood onset of the disease can cause physical deformities, and physical incompetence at work. Researchers say that adults w...

Heart attack risk increased by depression

...e same. The study was conducted on 60,000 patients submitted by 644 general practices. At first glance, results showed both the newer and older classes of antidepressants increased the risk of a first heart attack within the first month of being prescribed.The older class of tricyclic antidepressants (TCAs) w...

Young Patients On Antidepressants Found To Be Associated With Suicidal Tendencies

... those taking placebo. In the review of 477 trials submitted ,researchers say they found no evidence that SSRIs increased risk of suicide and neither did researchers find any evidence of an increased risk of suicidal thoughts, and of self harm. Researchers also compared the data of more than 146,000 patients ...

New Drug for Diabetes

...dditional studies were conducted, the research was submitted again to the FDA in June 2003. The final decision on this drug, which will be marketed as SYMLIN, is expected no later than December 2003....

A new way out for heroin addicts

...eceived weekly individual counseling sessions, and submitted regular urine samples for analysis to detect drug use. Researchers found that three-quarters of those in the first group (i.e. those who received buprenorphine daily) remained in the treatment program one year later compared to none of those in the ...

Plavix Gets FDA Okay for New Indication

...pproval for acute coronary syndrome, Bristol-Myers submitted data from a trial that was published in The New England Journal of Medicine. In that study, Plavix reduced the risk of heart attack, stroke or cardiovascular death by 20% in acute coronary syndrome patients, when compared with placebo....

Northfield Labs Receives FDA Comments

...(CBER) on its Biologics License Application (BLA), submitted August 2001. CBER indicated that they are seeking additional information before accepting the application for filing and issued a Refusal-to-File letter to the company. " Refusals for first-time submissions are common,'' said Richard DeWoskin, chief...

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 th...

'Sweaty palms syndrome' can be cured by surgery

...ry held in Helsinki, Finland. These patients were submitted to a questionnaire about the amount of stress they experienced in their daily life as a consequence of the constant sweating before surgery, and again at 2 weeks, 6 months and 1 year after surgery. On a scale of 1 through 10, with 10 signifying the ...

NEW ROBOTIC SURGERY ARM APPROVED BY FDA

...ew of clinical studies of safety and effectiveness submitted by the manufacturer and on the recommendation of the General and Plastic Surgical Devices Panel of FDA's Medical Devices Advisory Committee. Results showed that the robotic system was comparable to standard laparoscopic surgery in safety and effectiv...

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