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Barr Sued Over FazaClo ANDA

[ Price : $8.95]

Azur Pharma files a patent infringement suit against Barr Laboratories involving its recent ANDA for a generic copy of FazaClo.

Public Hearing on Pediatric OTC Cough/Cold Drugs

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Federal Register Notice: FDA plans a public meeting 10/2 in Beltsville, MD on OTC cough and cold drugs marketed for pediatric use.

Approved NMEs at 24-year Low

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Parexels drug approval trend analysis shows a 24-year low in NME approvals but an increase in the number of NME submissions.

FDA To Require Amended Tysabri Labeling

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FDA says it will require Biogen Idec to amend multiple sclerosis therapy Tysabri after two European patients developed progressive...

Noven Says Daytrana Problem Cause Found

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Noven Pharmaceuticals says it believes it has identified the root cause of a release liner problem in some Daytrana ADHD patches.

Info Sent to OMB on Certifications Accompanying Applications

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Federal Register Notice: FDA sends a proposed collection of information on a certifications to accompany applications to FDA.

Info on Fast Track Programs Sent to OMB

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Federal Register Notice: FDA sends a proposed collection of information on fast track drug development programs to the Office of M...

FDA Proposes Info Collection on Drug Use in Pregnancy

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Federal Register Notice: FDA sends a proposed collection of information on the risks and benefits of prescription drugs for pregna...

Exclusivity OKd for Labeling Info Removal

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FDA grants three years exclusivity for an Aczone gel supplement removing labeling information based on a post-marketing study.

Aloxi Oral Formulation Approved

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FDA approves an oral capsule formulation of Eisais Aloxi for preventing chemotherapy-induced nausea and vomiting.