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Review Period Set for Xtandi

[ Price : $8.95]

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

FDA Amends Animal Drug Regs on Nitarsone NADAs

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Federal Register Final rule: FDA is amending the animal drug regulations to reflect the withdrawal of approval of three NADAs prov...

FDA Withdraws NADAs in Poultry Feed

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Federal Register Notice: FDA withdraws approval of 3 NADAs for the use of nitarsone in chicken and turkey medicated feed.

Panel to Discuss Duchenne Muscular Dystrophy Drug

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Federal Register Notice: FDAs Peripheral and Central Nervous System Drugs Advisory Committee will meet 1/22/16 to discuss a Sarept...

Biosimilars Council Weighs In on User Fee Reauthorization

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The Biosimilars Council says FDA should codify the currently outstanding biosimilars regulations to expedite access to these alter...

FDA Clears Life Spines Cervical Plate

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FDA clears a Life Spine 510(k) for the GRUVE Anterior Cervical Plate System for use in spinal surgeries.

FDA Approves New Pediatric Indication for LifeVest

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FDA approves a new pediatric indication for Zoll Manufacturings LifeVest, a wearable cardioverter defibrillator.

FDA Clears Oculus Seborrhea Gel

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FDA clears an Oculus Innovative Sciences 510(k) for its Microcyn-based SebDerm Gel, intended for use in managing and relieving the...

Info on Safety Labeling Changes Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information on a guidance on safety labeling changes to the Office o...

Vancomycin HCl Products Not Withdrawn for S&E

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Federal Register Notice: FDA determines that Vancocin, Vancoled, and Vancocin Hydrochloride were not withdrawn from sale for reaso...