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ISTA Files sNDA for Ocular Drug

[ Price : $8.95]

ISTA Pharmaceuticals submits a supplemental NDA for once-daily bromfenac ophthalmic solution as a treatment for ocular inflammatio...

FDA OKs new COPD Indication for Spiriva

[ Price : $8.95]

FDA approves Boehringer Ingelheim Pharmaceuticals Spiriva HandiHaler (tiotropium bromide inhalation powder) for reducing exacerbat...

Companies Should Re-train on DDMAC 'Rules'

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Attorney Arnold Friede says that drug companies need to be aware of the rules that CDERs DDMAC applies when evaluating presentatio...

Roche Discontinues Zenapax Production

[ Price : $8.95]

Roche decides to discontinue production of Zenapax (daclizumab) sterile concentrate for injection, indicated for prophylaxis of a...

Early ANDA Submissions Cause Problems for Courts, FDA

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Attorney Kurt Karst says that FDA and federal courts are concerned that companies filing ANDAs many years before they expect to be...

Public Citizen Warns Against Routine Tamiflu Use

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Public Citizen says that some Roche claims for Tamiflu havent been proven and healthy adults should not use the drug for routine f...

Hemispherx Submits Manufacuring Data for Ampligen

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Hemispherx Biopharma and its manufacturing subcontractor submit comprehensive new data to FDAs Seattle, WA regional office to addr...

FDA Adds Boxed Warnings to TNF-Blockers

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FDA releases 11/09 labeling changes for 44 drugs, including boxed warnings for the TNF-blocker class of drugs.

Former Restaurant Association Official Tapped as Hamburg Advisor

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Former National Restaurant Association chief administrative officer Molly Varney Muldoon joins FDA as commissioner Margaret Hambur...

FDA OKs Aurobindo Generic Zyrtec Syrup

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FDA gives final approval to Aurobindo Pharma for cetirizine hydrochloride syrup 1mg/mL, a generic copy of McNeil Consumer Healthca...