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FDA Opens Mexico City Office

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FDA opens a new Mexico City office to foster further collaboration with the Mexican government.

FDA Clears EnzySurge Wound Management Product

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FDA clears EnzySurges wound management product SilverStream.

FDA Approves Generic Aricept for Alzheimers Dementia

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FDA approves Mutual Pharmaceuticals generic form of Aricept orally disintegrating tablets.

Animal Drug Regs Change Sponsor to Intervet

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Federal Register Final rule: FDA amends the animal drug regulations to show a change of sponsor name and address from Schering-Plo...

FDA OKs Boehringer NADA for Diabetic Cats

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Federal Register Final rule: FDA approves a Boehringer Ingelheim Vetmedica NADA for veterinary prescription use of protamine zinc ...

FDA Clears Dilon Diagnostics Lesion-localization System

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FDA clears a Dilon Diagnostics 510(k) clearance for the GammaLMc lesion-localization system for molecular imaging biopsy guidance.

FDA OKs Lillys Zyprexa Relprevv for Schizophrenia

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FDA approves Eli Lillys Zyprexa Relprevv for extended release injectable suspension for treating schizophrenia in adults.

Alexza Submits Staccato NDA

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Alexza Pharmaceuticals submits an NDA to FDA for its Staccato loxapine inhalation drug for treating agitation in patients with sch...

FDA Seeks New Trial for Vion Drug

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FDA issues Vion Pharmaceuticals a complete response letter for its NDA for Onrigin (laromustine) injection, finding the submission...

Panel to Consider Best Use of Tarceva

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FDA asks its Oncologic Drugs Advisory Committee to consider whether Roche/OSIs Tarceva should be approved as a first-line maintena...