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Mylan Announces Tentative FDA Approval for Divalproex Sodium Extended-Release Tablets
Mylan Pharmaceuticals has received tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA)...

FDA approves Hemophilia drug
Wyeth Pharmaceuticals said that it has received approval from the U.S. Food and Drug Administration (FDA) for new product enhancements for BeneFIX(R) ...

FDA Tells House Committee that Scientific Expertise Exists for Review of Biogenerics
Generic Pharmaceutical Association (GPhA) President and CEO Kathleen Jaeger issues the following statement on House Committee on Oversight and Governm...

Final PDUFA Recommendations Transmitted to Congress Will Strengthen Drug Review and Drug Safety
The FDA recently submitted to Congress its final proposal for reauthorizing the Prescription Drug User Fee Act (PDUFA IV) after reviewing public comme...

Medical Ventures Receives FDA Clearance for PeriPatch Aegis
Medical Ventures has received 510(k) clearance from the U.S. Food and Drug Administration for its new PeriPatch Aegis, a product designed to reduce co...

Roche Submits Application to the FDA for use of XELOX (Xeloda) plus oxaliplatin) With or Without Avastin for the Treatment of Advanced Colorectal Cancer
Roche announced the submission of a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) for the use of Xeloda (cap...

CISBIO Announces FDA Approval of MESOMARK
CISBIO, developer of diagnostic assays for the quantification of tumor markers, announced that the MESOMARK Assay, the world’s first in vitro test for...

European Union CHMP Recommends Approves Biologic Treatment for Pediatric Crohn's Disease: REMICADE
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) issued a positive opinion recommending the approval ...

FDA Finalizes Report on 2006 Spinach Outbreak
The FDA and California’s Department of Health Services (CDHS) today released a joint report on an extensive investigation into the causes of an E.coli...

FDA Warns Again About Arsenic in Mineral Water
The Food and Drug Administration (FDA) is re-issuing its warning to consumers not to drink "Jermuk" brand mineral water due to the risk of exposure to...

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