This reduced the amount of time the company actually had the patented drug on the market.
And besides Epogen and Neupogen, Amgen has only one other drug on the market: Hepatitis C treatment Infergen.
The drug was expected to be a big driver of growth for Ivax because it had the only copycat version of the drug on the market.
The FDA issued a conditional approval for Strattera on Aug. 14 but said that some new clinical studies might be needed to get the drug on the market.
Many doctors were as surprised as investors, because a panel of 32 experts had voted narrowl to keep the drug on the market--yet the agency made the opposite decision.
Changes announced to two big clinical trials aimed at getting the drug on the market in the U.S. and other companies probably mean that it probably does add some bleeding risk.
Organon chemist Anton Bom had the radical idea of making a drug that targets another drug, rather than targeting a protein, as just about every other drug on the market does.
America may have five times as many biotech firms as Britain, and scores of real products to show for its efforts (only one British firm, Chiroscience, actually has a drug on the market), but Britain has its own powerhouses around Oxford and Cambridge, and in Surrey and central Scotland, to compare with American clusters around Boston and San Francisco.
The Food and Drug Administration has chosen to leave Avandia, the GlaxoSmithKline diabetes drug, on the market, with restrictions.
At a showdown meeting next week, an FDA advisory committee will vote on whether the drug should stay on the market, in a culmination of years of controversy over whether the drug causes heart attacks or not.
For instance, if all the diabetes experts on the panel say they need the drug to remain on the market, this might be important even if they were outvoted by cardiologists and drug safety experts who say Avandia should be withdrawn.
Astra notes that its formulation patents were filed in 1987, two years before the drug came on the market.
Zelnorm "is a loss, but we will overcome it, " says Vasella, who hopes to get the drug back on the market eventually.
The panel will vote on whether or not the drug should stay on the market, and what warnings should be given to patients if it is not withdrawn.
On Wednesday, the same FDA panel will discuss whether to keep Meridia, an Abbott weight loss drug, on the market at all after data show it may cause heart attacks.
During the first 180 days a generic drug is on the market, the generic company has a virtual market monopoly for its formulation.
Eventually, a panel of advisers to the FDA decided that there should be more warnings on Avandia's label, but that the drug should stay on the market.
Once a drug is on the market, physicians are free to prescribe it for other conditions, though drug companies can't promote such off-label uses.
It is unclear whether the drug will remain on the market in these places.
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And as Genzyme's Mr Tambuyzer notes, rare diseases become less rare once a drug is on the market.
For Vioxx, the vote was likewise close, with the panel voting 17-to-15 that the drug should be on the market.
But the drug will stay on the market as it was concluded that the product did more good than harm.
At the very best, the first hints of these problems came from a re-analysis of data--an unreliable technique--two years after the drug had been on the market.
That summer a panel of FDA consultants voted 20 to 3 that Avandia probably does increase the risk of heart attacks but also voted 22 to 1 that the drug should stay on the market.
There is still a long way to go before millions of patients take 301012 to prevent heart attacks--although the drug could be on the market to help some exceptionally sick people in just a few years.
The document, written by John Jenkins, the director of the Office of New Drugs, and Paul Seligman, director of the office that handles statistical science and epidemiology, clearly spells out the reasons for the Bextra recall and what Pfizer (nyse: PFE - news - people ) would have to do to get that drug back on the market.
Perhaps the rationale for the continued use of diclofenac is rooted in the fact this drug has been on the market for 40 years and that physicians feel comfortable with it, despite the warnings.
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The FDA does have emergency powers to put a drug or vaccine on the market soon, and Adams said that was a distant possibility if something went awry in the federal supply line for the H1N1 vaccine.
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The panel had other ideas: It voted 11 to 3 that the drug should be allowed on the market for the sickest patients.
The FDA approved the drug and kept it on the market for a long time, despite a very modest weight loss benefit and obvious problems with the safety of the drug.
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