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CGMP Problems at Ben Venue

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FDAs Cincinnati District Office warns Ben Venue Laboratories over cGMP deviations found in its manufacturing facility.

FDA OKs Abilify As Adjunctive Therapy

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FDA approves an Otsuka supplemental NDA for atypical antipsychotic Abilify as adjunctive treatment to antidepressant therapy for t...

Senators Want to Talk to Former GSK Exec

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Sens. Baucus and Grassley want to interview former GSK research chairman Tadataka Yamada about his role in alleged company efforts...

FDA Six-month Review on Biovails Bupropion

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FDA assigns a six-month review to Biovails recently submitted complete response to its not approvable letter received in July on B...

FDA Approves Avalide sNDA

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FDA approves a sNDA for Sanofi-Aventis and Bristol-Myers Squibbs fixed dose combination antihypertensive Avalide.

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites All Medicus and Ben Venue Laboratories.

FDA Safety Alert on Pfizers Chantix

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FDA says it is reviewing postmarketing safety reports from Pfizer on its smoking cessation drug Chantix, including reports of suic...

Barr Submits ANDA for Generic Focalin

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Barr Pharmaceuticals submits an ANDA for a generic copy of Novartis Focalin XR.

Info on Animal Drug User Fees Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information on the animal drug user fee cover sheet to the Office of...