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Vivitrol Ad Omits Risk Information: OPDP

[ Price : $8.95]

The CDER Office of Prescription Drug Promotion warns Alkermes about a misleading Vivitrol print ad that omits important risk infor...

Xolair sBLA for Treating Nasal Polyps

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FDA accepts for review a Novartis supplemental BLA for Xolair (omalizumab) for treating nasal polyps in adult patients who do not ...

OTC Drug Reform Passes Senate

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The Senate votes 91-2 to approve legislation to reform the over-the-counter drug regulatory system.

Panel Rejects Correvios Vernakalant Over Safety

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FDAs Cardiovascular and Renal Drug Advisory Committee votes 11-2 against recommending approval of Correvio Pharmas vernakalant for...

Sozo Cleared for Assessing Protein Calorie Malnutrition

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FDA clears an ImpediMed 510(k) for Sozo, intended for use as an aid in assessing protein calorie malnutrition.

Courts Could See FDA Warning Letter as Final Action

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Attorney Michelle Yeary says a DC federal court decision might open the way for FDA Warning Letters to be considered final agency ...

CRN Praises Court Decision in Fish Oil Case

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The Council for Responsible Nutrition praises the Supreme Courts refusal to hear an Amrin appeal of a fish oil dietary supplement ...

Vabomeres Regulatory Review Period Determined

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Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Rempex Pharmaceuticals Vabo...

Info Collection on Minor Use/Species Drugs

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Federal Register notice: FDA sends to OMB an information collection extension for Reporting Associated With Designated New Animal ...

CGMP Violations Found in Teligent Inspection

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FDA warns Teligent Pharma about CGMP and Field Alert Report violations in its manufacturing of finished pharmaceuticals.