Merck and Schering-Plough filed a new drug application for Zetia with the FDA in December 2001.
All signals point to this being one of the best times to submit a new drug application in years.
After completion of more pre-clinical studies, Short hopes to file Diversa's first investigational new drug application sometime next year.
The New Drug Application for this drug was filed in 2005, and approval, which was not certain, took over 5 years.
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On the horizon, Novartis just submitted a new drug application for an arthritis drug, Prexige, to the U.S. Food and Drug Administration.
The new drug application for dalbavancin should be submitted by year's end.
Onyx and Bayer filed their new drug application first, but that left analysts and investors guessing as to when Pfizer would file its new drug application.
In fact, a supergeneric will sometimes need a completely new drug application in order to gain approval from the Food and Drug Administration (FDA).
In 1994, Marion Merrill Dow, now part of Sanofi-Aventis, filed a new drug application for the drug as a treatment for all kinds of epilepsy.
The FDA had initially declined to approve Zioptan, sending Merck a "complete response" letter in November asking for more information about the new drug application.
InterMune announced that the FDA has posted briefing documents for the March 9 Pulmonary-Allergy Drugs Advisory Committee meeting to review their New Drug Application for pirfenidone.
Monday Takeda said the FDA recommended it suspend top doses of TAK-475, and said the agency wants additional clinical data before Takeda submits a new drug application.
Sanofi-Aventis ( SNY - news - people ), filed a new drug application for the drug as a treatment for all kinds of epilepsy.
The FDA had never closed the file on the drug, and in December 2007, Shields' data formed the basis of a new drug application for infantile spasms.
The FDA is currently considering a new drug application for Zetia, a cholesterol medicine Schering is developing with Merck (nyse: MRK - news - people ).
Pfizer also said this morning that the Food and Drug Administration refused to accept a new drug application for an experimental medicine the company got from its acquisition of FoldRx.
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Vivus resubmitted its new drug application for Qnexa in October with a contraindication for women of childbearing age, and is studying the impact of the drug in pregnant women and babies.
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Some key background: In May 2003, Paddock filed an Abbreviated New Drug Application (ANDA) with FDA for approval of a generic version of AndroGel, as did another generic producer, Watson Pharmaceutical.
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Today's announcement will likely give investors more confidence that the drug will be approved for head and neck cancer patients, despite a delay in filing a new drug application for that indication.
Similarly, a drug developer could be awarded a transferable right of priority (rapid) FDA review for a new drug application as an incentive for developing a new product to treat a rare disease.
Bayer and Onyx will prepare a new drug application in the United States based on the information, but the trial will continue to see if their pill, code-named BAY 43-9006, extends patients' lives.
Late last year, it submitted a new drug application to the FDA, hoping to market Lyrica as a treatment for fibromyalgia, a chronic, widespread pain that Pfizer says afflicts tens of millions of people.
Those numbers mirror the results ImClone boasted of in 2001, before the U.S. Food and Drug Administration rejected a new drug application on the grounds that the data were not sufficient to prove that Erbitux worked.
The two companies filed a New Drug Application on Jan. 9, 2009 and learned in November that the agency extended the review date of Horizant to Feb. 9 to perform a risk evaluation and mitigation plan for the drug.
Maybe CMS should automatically begin reviewing a device as soon as a new drug application has been submitted to the FDA. That could not only get devices to patients faster, but also allow for more debate on medical costs, earlier.
The gamble paid off, as Merck was able to file a new-drug application six weeks before Novartis.
For the first time in a decade, Merck has to pull an FDA application for a new drug.
Waksal sold his ImClone holdings after finding out the government was going to reject an application for a new cancer drug being developed by his company.
Today, Bristol-Myers (nyse: BMY - news - people ) and ImClone (nasdaq: IMCL - news - people ) submitted a new application for approval of the drug, far sooner than many skeptics had predicted.
India's patent office rejected the company's patent application, arguing the drug was not a new medicine but an amended version of its earlier product.
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