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News Breaks
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November 20, 2009
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| 07:33 EDT |  | COV |
| theflyonthewall.com: | FDA sets new action date for review of Covidien's new drug | | Covidien announced that the U.S. FDA has set a new action date under the Prescription Drug User Fee Act for the review of the New Drug Application, or NDA, for Exalgo, or hydromorphone HCl extended-release, Tablets CII, of February 22, 2010. Neuromed Pharmaceuticals and Covidien recently provided the FDA with supplemental information, which the agency determined to be a major amendment to the NDA. As a result, the FDA has extended its action date by three months to allow more time to review the application. The proposed indication for Exalgo is once daily administration for the management of moderate to severe pain in opioid tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time. :theflyonthewall.com |
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News For COV From The Last 14 Days Check below for free stories on COV the last two weeks.
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February 9, 2012
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| 09:36 EDT |  | COV |
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February 8, 2012
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| 23:32 EDT | | COV |
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February 3, 2012
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| 07:39 EDT |  | COV |
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February 2, 2012
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| 14:05 EDT | | COV |
| theflyonthewall.com: | FDA and industry reach agreement in principle on medical device user fees | | The FDA and representatives from the medical device industry have reached an agreement in principle on proposed recommendations for the third reauthorization of a medical device user fee program. The recommendations would authorize the FDA to collect $595M in user fees over five years, plus adjustments for inflation. Details of the agreement, such as the fee structure, are expected to be finalized soon. :theflyonthewall.com |
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February 1, 2012
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| 16:28 EDT | | COV |
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January 30, 2012
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| 07:07 EDT | | COV |
| theflyonthewall.com: | Covidien device approved for interventional management of stroke trial | | Covidien announced that the Solitaire FR Revascularization Device has been approved for investigational use in the Interventional Management of Stroke trial. The Solitaire FR device was approved by the IMS III Executive Committee in the thrombectomy arm of the trial and was included in a recently approved amendment submitted to the FDA. :theflyonthewall.com |
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