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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.

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 ...

FDA Approves Baxter Expanded Indication for Artiss

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FDA approves an expanded indication for Baxter International's Artiss [fibrin sealant (human)] to include adhering tissue flaps du...

Enforcement Request Petition Denied for Azithromycin

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FDA denies a citizen petition seeking enforcement action against three companies selling generic azithromycin that the petitioners...

Former HHS General Counsel Joins King & Spalding

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Former HHS acting general counsel Preeya M. Noronha joins King & Spalding's FDA and life sciences practice as counsel in Washingto...