Pozen: FDA Needs More Trexima Data
AP
Pozen: FDA Needs More Trexima Data
Wednesday December 13, 8:16 am ET
Pozen Needs to Submit More Data to FDA for Approval of Proposed Migraine Treatment Trexima
CHAPEL HILL, N.C. (AP) -- Pain drug developer Pozen Inc. said Tuesday that the Food and Drug Administration requested more information to assess the safety of company's proposed migraine treatment Trexima.
The company submitted more information in November per an agency request, but the FDA said the response was not complete and has asked for additional analyses and supporting information.
Pozen originally received an "approvable letter" for Trexima in June, meaning the agency thought the company's drug marketing application was in order but that more details were needed for final approval.
Pozen plans to submit the new response by the end of the year.
Pozen: FDA Needs More Trexima Data
Wednesday December 13, 8:16 am ET
Pozen Needs to Submit More Data to FDA for Approval of Proposed Migraine Treatment Trexima
CHAPEL HILL, N.C. (AP) -- Pain drug developer Pozen Inc. said Tuesday that the Food and Drug Administration requested more information to assess the safety of company's proposed migraine treatment Trexima.
The company submitted more information in November per an agency request, but the FDA said the response was not complete and has asked for additional analyses and supporting information.
Pozen originally received an "approvable letter" for Trexima in June, meaning the agency thought the company's drug marketing application was in order but that more details were needed for final approval.
Pozen plans to submit the new response by the end of the year.
posted by B at 7:48 PM
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