Porges points out that there is an FDA-mandated safety study of Copaxone in combination with Tysabri.
In contrast, ImClone's development plan--not least its relationship with the FDA--has been seriously botched so far.
Other doctors--and the FDA--are increasingly saying the same thing, and not just with Peg-Intron and Pegasys.
The experiments usually test things like vitamins that are already FDA-approved or sold over-the-counter.
It is also the only system of its kind that is an FDA-registered medical device.
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Byrne said combining independent science with law-making in an FDA-type committee would erode democratic accountability.
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Research shows counseling and FDA-approved anti-smoking drugs are the most effective ways to quit, Fiore said.
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Consumers who are unsure about UV blocking in lenses can ask the optometrist for the FDA-approved package insert.
So there are solid reasons why pharma sales reps should stick to promoting Xyrem for only FDA-approved uses.
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There was no statistically significant difference in the development of FDA-defined valve abnormalities between Belviq and placebo-treated patients.
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One such idea is colloidal silver, which works but isn't patentable for human consumption because it isn't FDA-approved.
The only FDA-approved weight loss medications are sibutramine (Meridia), orlistat (Xenical), and phentermine.
"'FDA-approved' is just about as good a brand as we have, " said Dodd.
The number of new FDA-approved drugs is down sharply from a year ago.
It is an FDA-approved hearing aid, but it is sold online and preprogrammed for typical mild to moderate hearing loss.
It is the first FDA-approved clinical trial to inject fetal stem cells directly into the spinal cord of an adult.
The problem for Glaxo was that its own analysis--which it had quietly shared with the FDA--was consistent with Nissen's result.
The drug is the first and the only FDA-approved treatment for DME patients, which are treated by laser surgery otherwise.
The company keeps on trying to find new ways to expand the application of its two FDA-approved drugs to other diseases.
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The company has been in a race to develop an FDA-approved obesity drug, with rivals Arena Pharmaceuticals (ARNA) and Orexigen (OREX).
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As of now, there is no FDA-approved treatment for dry macular degeneration, although a few drugs and devices are in clinical trials.
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The drug Mylotarg, generic name Gemtuzumab ozogamicin, was FDA-approved for post-remission treatment of AML in patients over age 60 several years ago.
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Congress requires Medicare to reimburse for any FDA-approved drug regardless of cost-effectiveness.
The consumer giant has linked up with Noven Pharmaceuticals, a Miami outfit that already makes an FDA-approved two-hormone patch for women in menopause.
You also can look for an FDA-approved health claim on breakfast cereals if at least half the cereal is made with whole grains.
Therefore, the Phase III LibiGel (testosterone gel) safety study will continue as per the FDA-agreed protocol, without modifications including continued enrollment of new subjects.
For instance, only about two out of 10 programs use one of the FDA-approved medications for treating drinking problems, such as Naltrexone or Antabuse.
What if a company develops an improvement to an FDA-approved product?
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At that time, the group said that there had been 85 recalls of FDA-regulated foods since the House of Representatives passed its version of the bill.
The shift into pharma gained speed when the company, later renamed Jubilant Life Sciences, acquired a U.S. FDA-approved pill-and-capsule plant in the U.S. in the mid-2000s.
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