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United Therapeutics Subpoenaed on Marketing of 3 Drugs

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HHS Office of the Inspector General issues United Therapeutics a subpoena requesting documents on Remodulin (treprostinil) for inj...

CDER Completes Generic Drug Super Office Reorganization

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CDER completes a year-long reorganization of the Office of Generic Drugs to a super office.

Supreme Court Wont Hear Pfizer Neurontin Marketing Case

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The U.S. Supreme Court declines to hear an appeal by Pfizer related to several lawsuits involving its promotion of Neurontin for p...

Animal Drug Regs Reflect October Approvals, Sponsor Change

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Federal Register final rule: FDA amends the animal drug regulations to reflect October approval actions and to reflect a change of...

FDA Denies Novartis Petition Seeking Generic Approval Delay

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FDA rejects a Novartis citizen petition for reconsideration that asked the agency to not approve any ANDA for a zoledronic acid IV...

FDA-483 Cites Biogen-Idecs Tysabri and Avonex Operations

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A just-posted FDA Form-483 cites Biogen-Idecs manufacturing and control operations involving the active pharmaceutical ingredients...

FDA Sees Some Benefit in Myalept, But Also Safety Concerns

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FDA says an Amylin Pharmaceuticals BLA for Myalept (metreleptin) has shown some benefit in a subgroup of patients suffering from l...

FDA Plans Interim Move To White Flint

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FDA reaches an agreement to lease space in a new building next to the White Flint Metro station in Rockville, MD for agency employ...

CDER Draft Guide on Generic Drug Tablet/Capsule Sizes

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A new CDER draft guidance encourages generic drug manufacturers to consider physical attributes when they develop quality target p...

Gileads Solvaldi for Hep C Approved

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FDA approves a Gilead NDA for Sovaldi (sofosbuvir) to treat chronic hepatitis C virus infection.