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Intellipharmaceutics ANDA for Generic Focalin

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Intellipharmaceutics International submits an ANDA for a generic copy of ADHD drug Focalin XR (dexmethylphenidate hydrochloride) 3...

No Support Found for Whistleblower GAO Complaints

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The Government Accountability Office inspector general says no evidence was found to substantiate whistleblower allegations that G...

FDA Temporary Budget Extended for Two Weeks

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President Obama approves a temporary FDA budget extension until 12/18 for FY 2011 under a continuing resolution.

Firms Paying $421 Million in False Claims Settlement

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Three drug companies agree to pay $421 million to settle whistleblower False Claims Act suits.

Compliance Guide on Vacuum Switches Withdrawn

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Federal Register Notice: FDA withdraws an obsolete compliance policy guide on the definition of high-voltage vacuum switch.

Advisors Recommend Contrave Approval

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Members of FDAs Endocrinologic and Metabolic Drugs Advisory Committee recommend that FDA approve Orexigens Contrave for weight los...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites OsteoSymbionics, Steris, and Vanderveer Center.

Inspection Sees CGMP Problems in Cranial Plate Implant Manufacture

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FDAs Cincinnati District Office warns OsteoSymbionics about CGMP violations at its cranial plate implant manufacturing facility.

Topaz Nearing NDA for Head Lice Treatment

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Topaz Pharmaceuticals says it plans a 2011 NDA submission for its ivermectin topical cream as a treatment for head lice.

FDA Releases Report on Graphic Cigarette Labeling

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Federal Register Notice: FDA adds a research study to the docket proposing required warnings and graphics on cigarette packages.