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FDA Approves an Edgemont NDA for Fluoxetine 60mg

[ Price : $8.95]

FDA approves an Edgemont Pharmaceutical NDA for fluoxetine tablets 60 mg, the active ingredient in Eli Lilly's Prozac.

Quality System Problems at X-Ray Support

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FDAs Seattle District Office warns X-Ray Support, Inc. about Quality System and registration violations in its manufacturing of de...

Labeling Content and Format Guidance

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FDA issues a guidance on content and format of specific labeling sections for human Rx drug products and biologicals.

Physical-Chemical Identifier Guidance

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FDA issues a guidance to help drug manufacturers incorporate physical-chemical identifiers into solid oral dosage forms.

EC Proposes Revised Rx Drug Information Requirements

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The European Commission proposes revising requirements on information that drug companies can give to the public on Rx medicines.

Info on Appeals to CVM Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information on appeals of science-based decisions at the Center for ...

Latest FDA Warning Letters

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In its latest batch of Warning Letters FDA cites Botanic Oil Innovations and X-Ray Support.

FDA Continues Hold on Cystic Fibrosis Trial

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FDA maintains a clinical hold on an Insmed Phase 3clinical trial for Arikace (liposomal amikacin for inhalation) in cystic fibrosi...

FDA Clears a Cardium Therapeutics 510(k) for Wound Product

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FDA clears a Cardium Therapeutics 510(k) for the Excellagen professional-use, sterile, syringe-based advanced wound care product f...

Banner Pharmacaps ANDA for Generic Targretin

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FDA accepts for review a Banner Pharmacaps ANDA for a generic version of Eisai's Targretin.