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FDA Approves 1st Generic Wellbutrin XL

[ Price : $8.95]

FDA rejects a citizen petition and approves the first generic Wellbutrin XL, submitted by Anchen Pharmaceuticals.

FDA Panel Votes Down Hemopure Navy Trial

[ Price : $8.95]

FDAs Blood Products Advisory Committee votes against allowing Biopure Corp. to proceed with a U.S. Navy-proposed study with the bl...

FDA Says Genasense Not Approvable

[ Price : $8.95]

FDA says Gentas Genasense is not approvable for use with chemotherapy in treating patients with chronic lymphocytic leukemia.

FDA to Take Action Against Unapproved Quinine

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Federal Register Notice: FDA plans to take enforcement action against unapproved drug products containing quinine, quinine sulfate...

Comments Sought on International Drug Restrictions

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Federal Register Notice: FDA seeks written comments on World Health Organization recommendations to impose international manufactu...

FDA Advisers Vote Against 2 of 3 Ketek Indications

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Two FDA advisory committees vote against two of three indications for Sanofi-Aventis troubled antibiotic Ketek, and recommend a bl...

Elan, Biogen Idec Seek New Tysabri Indication

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Elan Corp. and Biogen Idec file a supplemental BLA for Tysabri, indicated for treating moderate to severe active Crohns disease.

New Trasylol Labeling Limits Patient Population

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FDA approves seven changes to labeling for Bayers Trasylol.

People Want More Safety, Side Effects Info

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Respondents to a Pharmaceutical Safety Institute survey say they want more information on drug side effects and safety issues.

Baxter Conditional Approval on Colleague Pump Correction

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FDA gives Baxter Healthcare conditional approval for a plan to correct its troubled Colleague drug infusion pump.