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Repackaged Avastin Intravitreal Injections Causing Eye Infections

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FDA warns that at least 12 cases of serious eye infection have been reported in the Miami, FL, area after intravitreal injection o...

FDA Approves Dr. Reddy's Generic OTC Allegra

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FDA approves a Dr. Reddy's Laboratories ANDA for an over-the-counter (OTC) generic copy of Sanofi-aventis' allergy drug Allegra.

Avanir Sues Impax Over Proposed Generic Nuedexta

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Avanir Pharmaceuticals files a patent infringement suit against Impax Laboratories in connection with a recent Impax ANDA for a ge...

Authorized Generics Can Lower Prices: FTC

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The Federal Trade Commission says that authorized generics from innovator companies can provide a short-term reduction in drug pri...

Medtronic Begins Post-approval Study of Endurant Stent Graft

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Medtronic begins a post-approval study in the U.S. of its Endurant AAA Stent Graft System indicated to treat abdominal aortic and ...

Plea Bargain Reported Near for CDER Chemist

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Attorneys involved in the governments prosecution of a CDER chemist accused of insider trading say a plea agreement may soon be fi...

Guidance on PET Drug NDAs and ANDAs Out

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FDA issues a guidance to help sponsors file NDAs and ANDAs for three PET imaging drugs due by 12/9.

FDA Approves Lupin's Generic Ultram

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FDA approves a Lupin Pharmaceuticals ANDA for a generic copy of Ortho-McNeil's Ultram.

Panel Charter Changed to Include Analgesics

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Federal Register Final rule: FDA changes the name and function of the Anesthetic and Life Support Drugs Advisory Committee.

Guidance on Scored Tablets

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Federal Register Notice: FDA releases a draft guidance on labeling of tablets that have been scored.