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FDA Approves Mylans Generic Keppra

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FDA approves Mylans ANDA for a generic form of UCB Pharmas antiepileptic drug Keppra in three dosage strengths.

Expanded Norditropin Indicated OK

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FDA approves an expanded indication for Novo Nordisks Norditopin for treating short stature in children born small for gestational...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites the Center for Fertility and Gynecology.

FDA Finds Quality Issues at Caraco Plant

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FDA warns Caraco Pharmaceuticals on quality problems at its Detroit manufacturing facility.

FDA OKs Akorn-Strides Generic Aredia

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FDA approves an Akorn-Strides ANDA for a generic copy of Novartis Aredia.

Physicians Want More Off-label Limits

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Georgetown University Medical Center and private practice physicians say restrictions on off-label marketing should be much more s...

Info on Generic Drug User Fees Sent to OMB

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Federal Register Notice: FDA submits a collection of information on the burden hours required for the new Animal Generic Drug User...

Comments on Dispute Resolution Above Division Level

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Federal Register Notice: FDA seeks comments on the information collection contained in the guidance on formal dispute resolution i...

Panel to Hear CBER Updates

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Federal Register Notice: FDAs Vaccines and Related Biological Products Advisory Committee will meet 11/20.

Grassley Probes FDA Employee Pay/Benefits Complaints

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Senate Finance Committee ranking member Chuck Grassley (R-IA) investigates FDA employee allegations about mismanagement of agency ...