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FDAer Sees Latest Study on Bisphosphonates as Inconclusive

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An FDA epidemiologist says a new study showing that the risk of esophageal cancer increases with the number of oral bisphosphonate...

FDA OKs Intervet sNADA for Bovine Respiratory Disease

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Federal Register Final rule: FDA approves an Intervet, Inc. supplemental NADA to add to the list of bovine respiratory disease pat...

Animal Drug Sponsor Changed to Alpharma LLC

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Federal Register Final rule: FDA amends the animal drug regulations to reflect a sponsor name and address change to Alpharma LLC.

Change of Sponsor to Norbrook Labs

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Federal Register Final rule: FDA amends the animal drug regulations to reflect a change of sponsor for two NADAs to Norbrook Labor...

Review Period Set for Neurx Pacing System

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Federal Register Notice: FDA determines the regulatory review period for Case Western Reserve Universitys Neurx Diaphragm GM Pacin...

FDA Posts Approved PMAs

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Federal Register Notice: FDA publishes a list of PMAs that have been approved.

FDA OKs Bayer sNADA for Kittens

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Federal Register Final rule: FDA approves a Bayer HealthCare supplemental NADA for removing parasites in kittens.

Ceftaroline Appears Effective: FDA Reviewers

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FDA medical reviewers say Forests new antibiotic ceftaroline appears to be effective in treating some cases of community-acquired ...

Although Swamped, DDMAC is Sending More Letters

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Reuters says DDMAC continues to be swamped by the volume of drug marketing materials and its own inadequate technology.

Court Denies Vet Compounding Injunction

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A veterinary drug compounding pharmacy has resumed operations after a federal judge denies FDAs request for a temporary injunction...