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Gablofen Approved for Treating Spasticity

[ Price : $8.95]

FDA approves a CNS Therapeutics NDA for Gablofen (baclofen injection) for use in managing severe spasticity.

FDA OKs Boehringer sNADA for Dairy Cattle

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Federal Register Final rule: FDA approves a Boehringer Ingelheim Vetmedica sNADA for minor label revisions to Dry-Clox Intramammar...

Accutane NDA Withdrawn

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Federal Register Notice: FDA withdraws approval of Hoffmann-La Roches NDA for Accutane because the product is no longer marketed.

Impax Sued Over ANDA for Generic Welchol Suspension

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Daiichi Sankyo and Genzyme file a patent infringement suit against Impax Laboratories over a recently submittied ANDA for a generi...

Omthera Pharma Gains Protocol Agreement for Epanova Trial

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Omthera Pharmaceuticals and FDA reach agreement on a special protocol assessment on a planned Phase 3 trial involving Epanova for ...

FDA Allows Stem Cell Trial for Macular Degeneration

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FDA approves an Advanced Cell Technology IND to begin a Phase 1-2 multicenter clinical trial using retinal cells derived from huma...

FDA OKs Clinical Testing for OraSure HIV OTC Test

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FDA grants OraSure Technologies an investigational device exemption for the final phase of testing for the OraQuick Rapid HIV-1/2 ...

Cornerstone Withdraws Propoxyphene Products

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Cornerstone Therapeutics voluntarily withdraws three generic opiate propoxyphene products upon FDA request due to new clinical dat...

Merck to Seek FDA Approval for Vytorin Use in Kidney Patients

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Merck says it will seek FDA approval to expand the use of its cholesterol-lowering drug Vytorin for patients with kidney disease a...

Record Year For FDA-related Fines $1.8 Billion

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The U.S. Justice Department says fiscal year 2010 saw a record $1.8 billion in fines, forfeitures, and related actions under the F...