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FDA OKs Intervet NADA for Canine Incontinence

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Federal Register Final rule: FDA approves an Intervet NADA for use of estriol tablets to control canine urinary incontinence.

Guidance on Humanitarian Use Devices

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Federal Register Notice: FDA releases a draft guidance, on Humanitarian Use Device designations.

ProstaScint Fact Sheet Misleading: OPDP

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CDERs Office of Prescription Drug Promotion says an EUSA ProstaScint fact sheet fails to provide important information, overstates...

FDA Not Requiring REMS for Cushings Drug

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FDA tells Corcept Therapeutics that it will not require a Risk Evaluation and Mitigation Strategy program as part of its NDA submi...

Rep Cited for False, Misleading Latuda Statements

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CDERs Office of Prescription Drug Promotion says that a Sunovion sales representative made false or misleading statements about La...

OPDP Says Qutenza Booth Didnt Give Risk Info

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CDERs Office of Prescription Drug Promotion says that a convention display booth for NeurogesX Qutenza failed to communicate risk ...

Gilead Submits Truvada sNDA for New Indication

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Gilead says it is seeking a new indication for Truvada for pre-exposure prophylaxis to prevent HIV-1 infection.

Enforcement Discretion Under DESI Still Being Clarified

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Attorney Kurt Karst says FDA is further clarifying its enforcement discretion policy for drugs being marketed pending a DESI deter...

CVM Releases Info to Help Choramine-T Sponsors in Fish Disease

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FDA publishes safety and effectiveness information to support a new animal drug application (NADA) for use of chloramine-T for con...

FDA Restores Higher Simvastatin Dose with Amiodarone

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FDA says it erred in reducing the dose limitation for simvastatin when used in conjunction with amiodarone.