The LibiGel safety protocol specifically was approved by FDA after careful, thorough, and productive interactions.
Generic drugs approved by FDA are of the same high quality and strength as brand-name drugs.
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In March 2009, before Obama named Margaret Hamburg as commissioner of the FDA, I wrote that over the past five years only five of six antibiotics approved by the FDA were approved, and detailed the difficult path that another new antibiotic was having in trying to reach the market.
These drugs have been approved by the FDA and routinely prescribed by physicians all in the name of good health.
Of the two drugs, only Lucentis has been approved by the FDA to treat AMD, but recently a study by National Institutes of Health found Avastin to be equally effective.
One type of oral contraceptive has been approved by the FDA for treatment of acne.
Zetia and Vytorin were both approved by the FDA based on their ability to lower LDL cholesterol.
Bernstein, issued a note to investors saying she expected Iressa wouldn't be approved by the FDA panel.
An estimated 6 million people have taken Avandia since it was approved by the FDA in 1999.
The Erivedge capsule (Vismodegib) was approved by the FDA last year for the treatment of basal cell carcinoma.
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The government accused Amgen of marketing Aranesp for indications not approved by the FDA and other illegal marketing practices.
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Only 5 drugs have been approved by the FDA for use in merely slowing down the progress of the disease.
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The trials have already been approved by the FDA, and the Army has approved funding for the feasilibility trials in Baltimore.
As with prescription drugs, devices in this class must be approved by the FDA before they can be used on patients.
The artificial disc she needed had not yet been approved by the FDA but had been available since 2005 in Britain.
Three years after the controversial Provenge prostate cancer vaccine was approved by the FDA, Dendreon has finally released a television ad campaign.
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But now Botox has been proved to help migraine sufferers, and approved by the FDA, giving it legal entry into this market.
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However, should the fish be approved by the FDA, it will not be required to be labeled genetically engineered, per existing labeling guidelines.
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Happily, pomalidomide has been approved by the FDA and will be available to those who need it soon, marketed under the name Pomalyst.
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If approved by the FDA, the Quad treatment would be used by people living with HIV who are starting treatment for the first time.
Strattera, a nonstimulant treatment for attention deficit disorder, and osteoporosis drug Forteo have both been approved by the FDA and launched in the past few months.
In others, imitation Botox, or other imitation fillers not approved by the FDA, have left patients in comas for up to several years, and eventually dead.
At one point, Pfizer presented data about an injectable pain drug that has not yet been approved by the FDA, due partly to especially serious concerns about heart risk.
Most genetic tests have not been approved by the FDA, said W. Andrew Faucett, director of the genomics and public health program at the Emory University School of Medicine.
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But there is more to running a successful pharmaceutical company than just the number of products being approved by the FDA. What value do these new drugs generate?
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The best minds fighting myeloma worked into the night in the Hilton ballroom and designed the clinical trial that got Velcade, a life-extending treatment, approved by the FDA in 2003.
In December 2006, the first generic versions of the popular anti-depressant Wellbutrin XL were approved by the FDA. The drug comes in two dosage strengths, 150 milligrams and 300mg.
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With successful conclusion of this Phase III clinical program, LibiGel could be the first product approved by the FDA for women with low sexual desire, HSDD, a significant unmet medical need.
In March 2013, the Argus 2 was approved by the FDA for use in the United States and has the capacity to restore functional vision from people suffering from blindness.
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