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FDA OKs inhaled insulin: Alternative to injections for treating diabetes.
Byline: Bruce Japsen
Jan. 28--Offering millions of diabetics an alternative to being stuck with a needle, the U.S. Food and Drug Administration on Friday approved a first: inhaled insulin.
The FDA approved Exubera for both type 1 and type 2 diabetes, calling the new medication-delivery option a potential alternative for "many of the more than 5 million Americans who take insulin injections." It's the first new delivery mechanism for the treatment of adult patients with diabetes since the discovery of insulin in the 1920s.
Prior to the drug's approval, "patients with diabetes who need insulin to manage their disease had only one way to treat their condition," said Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research. "It is our hope that the availability of inhaled insulin will offer patients more options to better control their…
- FDA APPROVES Exubera(R).
- Press release article from: PR Newswire January 31, 2006 700+ words
...FEARFUL TO INJECT IT. NOW, THE FDA HAS APPROVED EXUBERA, THE FIRST INHALED AND NON-INJECTABLE...attacks, as well as blindness." EXUBERA HAS BEEN STUDIED IN PEOPLE WITH...DIABETES. SOME WITH TYPE 2 USED EXUBERA ALONE, AND SOME USED EXUBERA IN...
- MultiVu Video Feed: FDA Approves Exubera(R) (insulin human [rDNA origin])...
- Press release article from: PR Newswire January 27, 2006 700+ words
...with diabetes are treated. Exubera is an inhaled, rapid-acting...support@pathfire.com NEWS: Exubera: First Inhaled Insulin Receives FDA Approval FORMAT: News Package...Patient B-ROLL INCLUDES: ***Exubera Being Used By Diabetes Patients...
- Pfizer Receives FDA Approval for Exubera, the First Inhaleable Form of Insulin...
- Press release article from: Business Wire January 27, 2006 700+ words
...and the clinical development of Exubera. Nektar provides support in the manufacturing process for Exubera insulin, and manufactures the...inhalation devices. "Today's FDA approval of Exubera marks the beginning of a new era...
- UPDATE 4-Pfizer retracts CEO's report that FDA cleared Exubera.
- News wire article from: The America's Intelligence Wire January 27, 2006 700+ words
...believe that the FDA will either approve Exubera outright or at least...labeling before the FDA will allow it on...believe a key issue for Exubera would be with labeling...In September, an FDA advisory panel voted to clear Exubera for the treatment...
- UPDATE 3-Pfizer retracts CEO's report that FDA cleared Exubera.
- News wire article from: The America's Intelligence Wire January 27, 2006 700+ words
...believe that the FDA will either approve Exubera outright or at least...labeling before the FDA will allow it on...believe a key issue for Exubera would be with labeling...In September, an FDA advisory panel voted to clear Exubera for the treatment...
- UPDATE 5-Pfizer retracts CEO's report that FDA cleared Exubera.
- News wire article from: The America's Intelligence Wire January 27, 2006 700+ words
...believe that the FDA will either approve Exubera outright or at least...labeling before the FDA will allow it on...believe a key issue for Exubera would be with labeling...In September, an FDA advisory panel voted to clear Exubera for the treatment...
- Nektar Reports That FDA Advisory Committee Recommends Approval of Exubera(R)...
- Press release article from: Business Wire September 8, 2005 700+ words
...and sanofi-aventis who said that the companies will continue to work with the FDA to make Exubera available for patients in need. Pending FDA approval, Exubera would represent a major advance in insulin delivery and would be the first non...
- FDA Advisory Committee Recommends Approval of Exubera(R) for Use in Adults With...
- Press release article from: PR Newswire September 8, 2005 700+ words
...Pfizer and sanofi-aventis said that the companies will continue to work with the FDA to make Exubera available for patients in need. Pending FDA approval, Exubera would represent a major advance in insulin delivery and would be the first non...
- UPDATE 2-Pfizer retracts CEO's report that FDA cleared Exubera.
- News wire article from: The America's Intelligence Wire January 27, 2006 700+ words
...industrials. In September, an FDA advisory panel voted to clear Exubera for the treatment of Type 1...vote was nonbinding, the full FDA generally follows the recommendations...European Commission cleared Exubera. Exubera uses a powdered form...
- UPDATE 1-Pfizer retracts CEO's report that FDA cleared Exubera.
- News wire article from: The America's Intelligence Wire January 27, 2006 700+ words
...trading. In September, an FDA advisory panel voted to clear Exubera for the treatment of type 1...vote was nonbinding, the full FDA generally goes with the recommendations...European Commission also cleared Exubera. Exubera uses a powdered form...
Source: HighBeam Research, FDA OKs inhaled insulin: Alternative to injections for treating...
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