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FDA OKs Luitpold Pharma sNADA on Phenylbutazone

[ Price : $8.95]

Federal Register Final rule: FDA approves a Luitpold Pharmaceuticals NADA for a revised human food safety warning on phenylbutazon...

FDA OKs Elanco Animal Health Drug for Dog Fleas

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Federal Register Final rule: FDA approves an Elanco Animal Health NADA for veterinary prescription use of spinosad chewable tablet...

FDA OKs KV Pharmaceuticals Generic MS Contin

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FDA approves a KV Pharmaceutical Co. ANDA for a generic copy of Purdue Pharmas MS Contin.

FDA for Sale: Buy Now, or DTC Program Wont Start

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FDA puts its DTC television advisory reviews on sale for 120 days, saying that it needs at least $11.25 million or it wont be able...

Wyeth sNDA for Tygacils Use in Pneumonia

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Wyeth Pharmaceuticals submits a supplemental NDA for antibiotic Tygacil (tigecycline) for use in treating community-acquired pneum...

Biovail Submits New Data Analyses on Depression Drug

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Biovail submits a complete response to an FDA not approvable letter sent in July for its antidepressant BVF-033, a once-daily salt...

Draft Liver Injury Guidance Out

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FDA publishes a draft guidance for industry on laboratory requirements that signal a new drugs potential to cause liver injury.

Q&A Guidance on IVD Device Studies

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FDA issues a draft guidance to help sponsors and others develop in vitro diagnostic studies.

Noven Gets Approvable on Depakote Follow-on

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FDA issues Noven Pharmaceuticals an approvable letter on its NDA for Stavzor delayed-release capsules, a 505(b)(2) submission refe...

Fast Track Granted for HCV Therapy

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FDA grants fast track for Pharmassets R7128, an investigational therapy for treating chronic hepatitis C virus (HCV) infection.