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DDMAC: Xodol Sales Aid Widens Indication, Trims Risk

[ Price : $8.95]

DDMAC says a Victory Pharma professional sales aid for Xodol minimizes and omits risk information and broadens the indication.

FDA OKs Watsons Generic Razadyne

[ Price : $8.95]

FDA approves a Watson Pharmaceuticals ANDA for a generic copy of Ortho McNeil Janssens Razadyne ER.

FDA Accepts NDA for Sleep Drug

[ Price : $8.95]

FDA accepts for review a Transcept Pharmaceuticals NDA for Intermezzo, indicated for use as a sleep aid for treating those with in...

FDA OKs Genzymes Mozobil for Stem Cell Use

[ Price : $8.95]

FDA approves Genzymes Mozobil, an orphan drug intended to be used in combination with granulocyte-colony stimulating factor to mob...

New Approach Needed for Consumer Medical Info: FDA

[ Price : $8.95]

FDA says consumer medical information distributed with prescriptions doesnt meet congressional requirements for usefulness and a n...

FDA Orders Suicidality Warning on Epilepsy Drugs

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FDA says it is ordering antiepileptic drug manufacturers to add a warning on their product prescribing information about an increa...

Guidance on Orally Disintegrating Tablets

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Federal Register Notice: FDA releases a guidance on orally disintegrating tablets.

Guidance on Bioequivalence for Vancomycin HCl

[ Price : $8.95]

Federal Register Notice: FDA releases a draft guidance on bioequivelance recommendations for vancomycin HCl.

Guidance on Changes to Approved NADAs

[ Price : $8.95]

Federal Register Notice: FDA releases a draft guidance on changes to approved new animal drug applications that require the agency...

Guidance on AERs during Influenza Pandemic

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Federal Register Notice: FDA releases a draft guidance on postmarket adverse event reporting for medical products and dietary supp...