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More Recalls at McNeil Consumer Health Unit

[ Price : $8.95]

Johnson & Johnson's McNeil Consumer Health notifies FDA that it is recalling about 4 million packages of Children's Benadryl Fastm...

FDA Denies Propofol Petition

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FDA denies a citizen petition seeking enforcement action against Bedford Laboratories generic Diprivan for lack of conformity to c...

FDA Top Criminal Investigator to Retire

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FDA Office of Criminal Investigations director Terry Vermillion announces his retirement effective next month.

Micromedics Recalls 3 Devices Over Sterility

[ Price : $8.95]

Micromedics recalls its Surgical Sealant Dispensers, Nasal Septal Buttons, and Otological Ventilation Tubes because the products a...

FDA Tentative Approval for Generic Cymbalta

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FDA grants tentative approval to Impax Laboratories for a generic copy of Eli Lilly's antidepressant Cymbalta delayed-release (dul...

Impax Sued Over ANDA for Generic Welchol Suspension

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Daiichi Sankyo and Genzyme file a patent infringement suit against Impax Laboratories over a recently submittied ANDA for a generi...

Omthera Pharma Gains Protocol Agreement for Epanova Trial

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Omthera Pharmaceuticals and FDA reach agreement on a special protocol assessment on a planned Phase 3 trial involving Epanova for ...

FDA Allows Stem Cell Trial for Macular Degeneration

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FDA approves an Advanced Cell Technology IND to begin a Phase 1-2 multicenter clinical trial using retinal cells derived from huma...

FDA OKs Clinical Testing for OraSure HIV OTC Test

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FDA grants OraSure Technologies an investigational device exemption for the final phase of testing for the OraQuick Rapid HIV-1/2 ...

Cornerstone Withdraws Propoxyphene Products

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Cornerstone Therapeutics voluntarily withdraws three generic opiate propoxyphene products upon FDA request due to new clinical dat...