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Petition Seeks Doryx Equivalence Assurances

[ Price : $8.95]

Warner Chilcot and Mayne Pharma ask FDA to rule that enteric-coated doxycycline hyclate tablets are not equivalent to their Doryx.

Baucus Calls for 2009 Healthcare System Reform

[ Price : $8.95]

Sen. Max Baucus calls for healthcare reform that includes more restrictions on industry-physician relationships and greater enforc...

FDA Cites Indian Generic Maker After GMP Inspection

[ Price : $8.95]

Another Indian generic drug maker, Lupin, finds itself in FDA hot water after a recent inspection cited 15 manufacturing deficienc...

Sinus Science Web Site False, Misleading

[ Price : $8.95]

FDA warns Aerosol Science Laboratories that it is marketing an unapproved device and making unsubstantiated efficacy and superiori...

C-Path Institute Gets $9 Million for Critical Path

[ Price : $8.95]

Critical Path Institute (C-Path) wins a $9 million grant from Science Foundation Arizona to help it advance a streamlined drug dev...

Preliminary Injunction Standard Clarified

[ Price : $8.95]

The U.S. Supreme Court says plaintiffs seeking a preliminary injunction must show they will suffer irreparable harm without it.

Panel to Vote on Zephyr Endobronchial Valve

[ Price : $8.95]

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

[ Price : $8.95]

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

CSI Recalls Acne Cream

[ Price : $8.95]

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

[ Price : $8.95]

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