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FDA OTC Panel Turns to Decongestants

[ Price : $8.95]

FDAs Nonprescription Drugs Advisory Committee plans a 12/14 meeting to review re-formulated over-the-counter oral nasal decongesta...

Ex-FDAer Peg ORourke Joins Drug Consulting Firm

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Former FDA drug marketing regulator Margaret Peg ORourke joins the French drug industry consulting firm of Cegedim Dendrite.

Indevus Reintroducing Valstar Early Next Year

[ Price : $8.95]

CDER says Indevus Pharmaceuticals plans on re-introducing Valstar (valrubicin) by early 2008, following its removal from the marke...

FDA OKs Novartis Voltaren Gel

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FDA approves a Novartis NDA for Voltaren Gel, indicated for topical use in treating osteoarthritis pain.

AdvaMed Backs FDA Device Preemption

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AdvaMed urges the Supreme Court to support FDAs regulatory authority over medical devices and not allow a state liability suit to ...

FDA Orphan Status for TB Drug

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FDA grants a Sequella orphan drug status request for SQ109, an investigational drug for treating tuberculosis.

FDA OKs Genzymes Renagel Successor

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FDA approves a Genzyme Corp. sNDA for Renvela (sevelamer carbonate), indicated for controlling serum phosphorus in patients with c...

FDA Says Telavancin Approvable

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FDA says Theravances once-daily injectable antibiotic telavancin is approvable with conditions.

Merck Hopes 3rd Time is a Charm for OTC Mevacor

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Merck heads back to an advisory panel in December to seek support a third time for an over-the-counter version of cholesterol-lowe...

Arrow International Gets Fourth Warning Letter

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In an apparent lapse from Bush Administration policy against multiple Warning Letters to the same company, FDA sends a fourth Warn...