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FDA OKs Twice-weekly Premarin for Dyspareunia

[ Price : $8.95]

FDA approves an NDA supplement for a new indication for Premarin vaginal cream 0.5 g a twice-weekly dosing regimen to treat moder...

FDA Reports Resolved Shortage with Vinblastine

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FDA says APP Pharmaceuticals is reporting that its vinblastine sulfate injection is no longer in short supply.

Comment Sought on Formal Sponsor Meetings

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Federal Register Notice: FDA seeks comments on a guidance on formal meetings with sponsors and applicants for PDUFA products.

Participants Sought to Select CBER Panel Members

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Federal Register Notice: FDA requests industry participants in the selection of nonvoting industry representatives on CBERs adviso...

FDA Offices in China to Open

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FDA commissioner Andrew von Eschenbach opens FDAs three permanent offices in China next week.

Panel to Vote on Zephyr Endobronchial Valve

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Federal Register Notice: FDAs Anesthesiology and Respiratory Therapy Devices Panel will meet 12/5 to discuss an Emphasys Medical P...

FDA Accepts Watson NDA for 6-month Trelstar

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FDA accepts for review a Watson Pharmaceuticals NDA for a six-month formulation of Trelstar, indicated for palliative treatment of...

CSI Recalls Acne Cream

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CSI, USA recalls all lots of its 1- ounce tubes of benzoyl peroxide acne cream sold at three store chains.

Orion Sues Over Comtan Patent

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Orion sues Sun Pharma Global for patent infringement in Suns ANDA for generic Comtan.

FDA Considering Bisphosphonate Study

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FDA says it continues to monitor reports of atrial fibrillation in patients taking bisphosphonates and is considering additional r...