FDA Approvals - US FDA approves Lupin's Cefdinir (PharmaBiz) The US FDA has
US FDA approves Lupin's Cefdinir (PharmaBiz)
The US FDA has approved Lupin's Abbreviated New Drug Application (ANDA) for Cefdinir capsules 300mg.
FDA Approves Expanded Label for IV Antibiotic CUBICIN(R) to Add Bloodstream Infections Including Right-Sided Infective (Business Wire via Yahoo! Finance)
LEXINGTON, Mass.----May 25, 2006--Cubist Pharmaceuticals, Inc. today announced that the U.S. Food & Drug Administration has approved the supplemental new drug application for CUBICIN as once-a-day therapy at 6 mg/kg for the treatment of Staphylococcus aureus bloodstream infections including right-sided endocarditis caused by MSSA and MRSA .
ABIOMED Receives FDA Approval to Commence IMPELLA 2.5 U.S. Trial (Business Wire via Yahoo! Finance)
DANVERS, Mass.----May 25, 2006--ABIOMED, Inc. today announced that the U.S. Food and Drug Administration granted approval for the Company to commence its pilot clinical trial immediately in the United States for the IMPELLA 2.5 minimally invasive ventricular assist device .