The FDA also gave Byetta an "approvable letter" for its use as a single-agent therapy.
An "approvable letter" is usually one of the final steps before the FDA approves a drug.
However, a person who had spoken to people at Pfizer said the company had received an approvable letter.
On the face of the FDA's "not approvable" letter alone, the punishment meted out to Alkermes' stock seems unfair.
The approvable letter obliges the FDA to render a decision within six months (instead of ten) after its application is completed.
Instead, the FDA would probably grant an "approvable letter, " basically saying it will approve the drug if certain conditions are met.
Although the Food and Drug Administration (FDA) said the drug was approvable, it is not expected to hit the market until 2003.
The FDA issued what's euphemistically known as an "approvable" letter, saying that Provenge could be approved in the future if Dendreon passes more hurdles.
Overall, given the strength of 1- and 2-year weight-loss and the nature of FDA concerns, we continue to believe that Qnexa is an approvable drug.
Last year, Enzon Pharmaceuticals terminated its co-development agreement with Inex after the FDA issued a "non-approvable" letter for Marqibo, saying Phase III trials were necessary.
It might be approvable for patients whose schizophrenia is under control but who need to switch antipsychotics because their current drug is causing too much weight gain.
In June, the FDA had sent the company a "not approvable" letter regarding Zelnorm, saying that further studies would need to be conducted before it could be approved.
To review: lorcaserin is still a potentially approvable drug, but it could take a long time to get to market and approval is by no means a sure thing.
In a Sept. 23 note to investors, Merrill Lynch analyst David W. Munno, who covers antibiotic maker Cubist , a Vicuron competitor, wrote that he suspected Pfizer had received an approvable letter.
But, according to Wyeth, the FDA said in a "not approvable" letter to the company that the drug is not effective enough to be used in patients who need short-term treatment.
On Tuesday, Bristol and Merck said the U.S. Food and Drug Administration sent them a letter saying that Pargluva was approvable, but that more cardiovascular data would be needed if the drug were to be approved.
AstraZeneca (nyse: AZN - news - people ) just received a walloping piece of good mail: a letter from the U.S. Food and Drug Administration saying that its new cholesterol drug, Crestor, is approvable.
In a Sept. 23 note to investors, Merrill Lynch analyst David W. Munno, who covers antibiotic maker Cubist (nasdaq: CBST - news - people ), a Vicuron competitor, wrote that he suspected Pfizer had received an approvable letter.
And it does so to such a great degree that drug stocks tend to run up ahead of the so-called PDUFA date, a deadline by which the FDA must issue a public statement about whether a drug is approvable and what else a company needs to do to get it approved.
On Sept. 22, The Pink Sheet, a medical trade publication, reported the FDA had said that Pfizer received an "approvable letter" from the FDA. Such letters are not approvals but instead a kind of delay, saying that most of the data needed for approval are in but that additional steps need to be taken if the drug is to reach the market.
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