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FDA Accepts Vivus NDA for EvaMist

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FDA accepts for review a Vivus Inc. NDA for EvaMist, indicated for treating vasomotor symptoms associated with menopause.

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Dupaco, Health Dimensions, Radiometer Medical, Robert Ritch, Skytron, and Spoona...

FDA Proposes Convenience-Size Labeling

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Federal Register Proposed rule: FDA proposes to add to its labeling requirements a definition and the option of alternative labeli...

Time Change for Dispute Resolution Panel

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Federal Register Notice: FDA changes the time for the 12/15 meeting of the Medical Devices Dispute Resolution Panel.

FDA OKs Elanco sNADA for Swine

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Federal Register Final rule: FDA approves an Elanco Animal Health sNADA for an alternate feed regimen for tylosin phosphate in swi...

Neopharm Misses Phase 3 Endpoint with Cancer Drug

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Neopharm Inc. says a pivotal Phase 3 trial involving an experimental cancer drug failed to meet its efficacy endpoint.

Nature of Patient Conversations Affects Prescribing

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Researchers say doctors respond better to general requests for antidepressant medications rather than to requests for specific dru...

DTC Continues in New Zealand

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New Zealands government backs away from restricting drug DTC ads.

Gottlieb Resigns to Rejoin DC Think Tank

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FDA deputy commissioner for medical and scientific affairs Scott Gottlieb resigns his post at the agency to return to the conserva...

Injunction Against Apotex for Generic Plavix Upheld

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A federal appeals court judge keeps in place an injunction preventing Apotex from marketing its generic Plavix until a patent disp...