Abbott Seeks U.S. and E.U. Regulatory Approvals for HUMIRA(R) (Adalimumab) as a Treatment for Juvenile Rheumatoid ... (PR Newswire via Yahoo! Finance)
Abbott announced it has simultaneously submitted a supplemental Biologics License Application with the U.S. Food and Drug Administration and a Type II Variation to the European Medicines Agency seeking approval to market HUMIRA as a treatment for juvenile rheumatoid arthritis in the U.S. and juvenile idiopathic arthritis in the European Union .

Duramed's ENJUVIA(TM) (Synthetic Conjugated Estrogens, B) Tablets Receives Two New FDA Approvals (Medical News Today)
Duramed Pharmaceuticals, Inc., a subsidiary of Barr Pharmaceuticals, Inc. (NYSE: BRL), today announced that the Company has received two U.S. Food and Drug Administration (FDA) approvals related to its ENJUVIA(TM) (synthetic conjugated estrogens, B) product. The FDA has approved the Company's supplemental New Drug Application (sNDA) for 0. [click link for full article]