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Advisors Back New Vivitrol Indication

[ Price : $8.95]

FDAs Psychopharmacologic Drugs Advisory Committee recommends approval of a new indication for Alkermes Vivitrol to treat opioid de...

FDA Accepts Aricept Patch for Review

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FDA accepts for review an Eisai NDA for the Aricept Patch (donepezil transdermal system), indicated for treating mild, moderate an...

IND Co-development Specifics Sought

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Three groups make suggestions for FDA to consider in writing a guidance on co-developing investigational drugs.

FDA Begins Actos Safety Review

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FDA says it has begun a safety review of Takeda's diabetes drug Actos (pioglitazone) due to potential bladder risks.

FDA Corrects Small Error in Inhaler Rule

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Federal Register Final rule: FDA corrects a small error in a 4/14 final rule on removing essential-use designations for certain su...

Comments Sought on FDA, CMS Overlapping Reviews

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Federal Register Notice: FDA and the Centers for Medicare and Medicaid Services seek comments on what products would be appropriat...

Janssen Rejects FDA Risperdal Bioequivalence Recommendations

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Janssen says FDAs proposed bio equivalence requirements for generic intra-musculal risperidone will not be adequate.

FDA Clears Solta Laser for Removing Actinic Keratosis Lesions

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FDA clears a Solta Medical 510(k) for the Fraxel Re:store Dual laser for treating actinic keratosis lesions.

Boston Scientific Defibrillators OK'd for Certain Heart Failure Patients

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FDA approves a Boston Scientific PMA supplement for three cardiac resynchronization therapy defibrillators (CRT-D) to be used in t...

FDA Panel Nixes Arena Weight-loss Drug

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FDAs Endocrinologic and Metabolic Drugs Advisory Committee votes 9 to 6 to not recommend approval of Arena Pharmaceutical's weight...