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FDA Issues Tentative Approval for Intravenous Infusion Ciprofloxacin
SCHAUMBURG, Ill., Feb. 24 /PRNewswire-FirstCall/ -- American Pharmaceutical Partners, Inc. today announced it has received tentative approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for ciprofloxacin for intravenous infusion. Ciprofloxacin is indicated for a broad range of infections, including urinary tract, lower respiratory, nosocomial pneumonia, skin and skin structure, bone and joint and complicated intra-abdominal, and is the generic equivalent of Bayer's Cipro® I.V.
"Sales of ciprofloxacin were nearly $85 million in 2003," said Patrick Soon-Shiong, M.D., chairman, president and chief executive officer of American Pharmaceutical Partners. "Ciprofloxacin is an important anti-infective compound and we are pleased to add it to our future product offering. We expect to commence marketing this product upon the innovator's patent expiration in February 2006."
Source: American Pharmaceutical Partners, Inc.