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Valeant Challenging In Vitro Zovirax Bioequivalence

[ Price : $8.95]

Valeant Pharmaceuticals asks FDA not to approve any generic Zovirax ointment ANDAs providing in vitro bioequivalence data.

Novelos Therapeutics Has New Imaging Agent

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Novelos Therapeutics says it is developing CLR1502 (GLOW2), a preclinical cancer-targeted optical imaging agent for intraoperative...

Effient Not Superior to Clopidogrel: Researchers

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In a head-to-head trial, researchers say they did not find Eli Lilly blood-thinning drug Effient (prasugrel) to be superior to San...

FDA Allows Caraco to Resume Producing 2 Products

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FDA authorizes Caraco to resume production of two drug products at its Michigan facilities.

FDA Implements Misconduct Records System

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Federal Register Direct final rule: FDA implements a new systems of records on research misconduct proceedings.

Review Period Set for Torisel

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Federal Register Notice: FDA determines the regulatory review period for Wyeths Torisel for the purpose of patent extension.

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Alfa Vitamins Laboratories, Dragon Herbs, Healing Ways, and HSAC Enterprises, In...

FDA Cites Hospira Over Infusion Pump Manufacturing

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FDA cites Hospira over GMP deficiencies related to infusion pumps manufactured at the firms La Aurora de Heredia, Costa Rica facil...

Oncologists Restrict Drug Reps More than Other MDs: Report

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A ZS Associates physician access report says that oncologists are restricting drug company sales reps more severely than any other...

FDA Panel Review Set for Dynavax Hep B Vaccine

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FDA sets an 11/14-15 advisory committee review for Dynavax Technologies and its BLA for Heplisav, a vaccine for preventing hepatit...