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Approval Process Poses Headache for Chapel Hill, N.C.-Based Drug Maker.
Byline: Anne Krishnan
Jun. 2--The drug approval process is becoming a real headache for Chapel Hill-based Pozen Inc.
For the second time in less than a year, the U.S. Food and Drug Administration has rejected one of the firm's migraine drugs, surprising company officials and sending its stock sliding.
Pozen received a not-approvable letter Friday from the FDA for its MT 100 oral therapy, which combines an anti-nausea drug with a painkiller.
The company's stock plunged $4.31 to a 52-week low of $5.61 early Tuesday before closing at $6.23, down $3.69 in heavy trading. Pozen's 37 percent drop at the closing bell was the largest on the Nasdaq National Market on Tuesday.
"Based on our understanding of our many previous communications with the FDA and the information contained in the [new drug application], we are extremely surprised and very…
- POZEN'S New Drug Application for MT 100 for the Treatment of Migraine Accepted...
- Press release article from: Business Wire October 7, 2003 700+ words
...Drug Application (NDA) for MT 100 for the acute treatment...and Drug Administration (FDA). MT 100 is being developed as...POZEN submitted its NDA for MT 100 on July 31, 2003, seeking...approval in the U.S. The FDA has agreed to review the...
- Pozen's New Drug Application for MT 100 for the treatment of migraine accepted...
- News wire article from: Asia Africa Intelligence Wire October 7, 2003 700+ words
...Drug Application (NDA) for MT 100 for the acute treatment...and Drug Administration (FDA). MT 100 is being developed as...Pozen submitted its NDA for MT 100 on 31 Jul 2003, seeking...approval in the US. The FDA has agreed to review the...
- POZEN Submits New Drug Application to the U.S. FDA for MT 100 for the Acute...
- Press release article from: Business Wire July 31, 2003 700+ words
...Drug Administration (FDA) for the marketing approval of MT 100(TM) for the acute treatment of migraine. The FDA has agreed to review the...NDA submission to the FDA, POZEN announced on October...Authorization Application for MT 100 to the Medicines Control...
- POZEN Submits New Drug Application to the U.S. FDA for MT 300 for the Acute...
- Press release article from: Business Wire December 17, 2002 700+ words
...and Drug Administration (FDA) for marketing approval of MT 300 for the acute treatment...milestone for POZEN." MT 300 is designed to provide...therapy for severe migraine. MT 300 is being developed...in the development and FDA approval of our products...
- Pozen submits New Drug Application to the US FDA for MT 100 for the acute...
- News wire article from: Asia Africa Intelligence Wire July 31, 2003 700+ words
...the US Food and Drug Administration (FDA) for the marketing approval of MT 100 for the acute treatment of migraine. The FDA has agreed to review the NDA and to...carcinogenicity study in early 2004. MT 100 is being developed as an oral first...
- Pozen submits NDA to FDA for MT 300.(Brief Article)
- Newspaper article from: BioWorld Week December 23, 2002 700+ words
...file a new drug application for MT 300, its migraine treatment, by...regulatory submission was in the FDA's hands last week. MT 300 is a formulation of dihydroergotamine...president and chairman said, MT 300 should get its shot. Chapel...
- Pozen submits New Drug Application to the US FDA for MT 300 for the acute...
- News wire article from: Asia Africa Intelligence Wire December 17, 2002 700+ words
...Food and Drug Administration (FDA) for marketing approval of MT 300 for the acute treatment of migraine with or without aura. MT 300 is designed to provide long...injectable therapy for severe migraine. MT 300 is being developed as a new...
- POZEN Submits Final MT 100 Mouse Carcinogenicity Study Results to FDA.
- Press release article from: PR Newswire March 6, 2002 700+ words
...its lead product candidate, MT 100, to the Food and Drug Administration (FDA). The final results confirmed...findings that indicated that MT 100 was not carcinogenic in...results were submitted to the FDA in February. MT 100 is being developed as...
- POZEN Announces Favorable Results of Rat Carcinogenicity Study for MT 100 and...
- Press release article from: Business Wire January 28, 2004 700+ words
...Drug Administration (FDA) and completes the MT 100 New Drug Application...accepted for filing by the FDA in October 2003 and is currently in review. MT 100 is being developed...profile, POZEN believes MT 100, if approved by the FDA, should become the...
- POZEN Inc. Reaches Agreement With FDA to Submit Rat Carcinogenicity Study...
- Press release article from: PR Newswire February 20, 2002 700+ words
...Application (NDA) review period for MT 100, the company's lead...POZEN also confirmed that FDA approval of the MT 100 NDA is still dependent...latest discussions with the FDA, POZEN plans to submit its NDA for MT 100 in the first half of 2003...
Source: HighBeam Research, Approval Process Poses Headache for Chapel Hill, N.C.-Based Drug...
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