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FDA Accepts NeurogesX sNDA for HIV Neuropathic Pain

[ Price : $8.95]

FDA accepts a supplemental NDA from NeurogesX, Inc. for a 30-minute application of its Qutenza 8% for managing neuropathic pain as...

FDA Appeals Drug Compounding Case

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FDA appeals a Florida federal judges 9/12 ruling that the Federal Food, Drug, and Cosmetic Act does not give the agency the author...

Watson ANDA for Generic Exelon

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Watson Labs files an ANDA for a generic equivalent of Novartis Exelon patch used for treating mild to moderate dementia associated...

FDA OKs Watson Kadian Generic

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FDA approves a Watson Pharmaceuticals ANDA for morphine sulfate extended-release capsules, a generic of Actavis Kadian.

Serious BIMO Inspections Soar 10-fold

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New FDA statistics show that serious (OAI) CDER clinical trial-related inspections soared 10-fold in the past eight years and that...

FDA Complete Response on Iluvien NDA

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FDA issues a complete response letter for an Alimera Sciences NDA for Iluvien for treating diabetic macular edema.

FDA Approves IntelGenx Depressive Disorder Drug

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FDA has approved an IntelGenx NDA for CPI-300, indicated for patients with major depressive disorder.

FDA Lifts Hold on Interferon Cervical Lesion Trial

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FDA removes a clinical hold on Helix BioPharmas Phase 2-3 trial involving its topical interferon alpha-2b product in low-grade cer...

Guidance on IDE Clinical Investigations

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Federal Register Notice: FDA releases a draft guidance, FDA Decisions for Investigational Device Exemption (IDE) Clinical Investig...

FDA Clears Cardiosave Intra-aortic Balloon Pump

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FDA clears a Maquet Cardiovascular 510(k) for the Cardiosave intra-aortic balloon pump.