Spectrum Pharmaceuticals Inc announced that the US Food and Drug Administration (FDA) has accepted for filing its Abbreviated New Drug Application (ANDA) for ciprofloxacin. The filing was made by the Company's NeoJB subsidiary on behalf of J.B. Chemicals & Pharmaceuticals, Ltd. Upon approval of the ANDA and expiration of the patent in December 2003, JBCPL will manufacture ciprofloxacin and NeoJB will market the drug in the United States. The Company hopes to generate revenue from the sale of ciprofloxacin in 2004.
J.B. Mody, Chairman (JBCPL) said, “We are focused on our vision to exploit opportunities of the growing generic drug market in the United States. We have the expertise to manage four to five ANDA applications every year. We remain confident in our ability to produce high quality generic drugs at competitive prices, and in Spectrum's ability to pursue regulatory approvals and ultimately oversee the marketing of these drugs. We expect to expand our basket of generic products for the US in the years ahead.”
"We are pleased with the FDA acceptance of the ANDA filing for our first generic drug, ciprofloxacin," stated Rajesh C. Shrotriya, Chairman, Chief Executive Officer and President of Spectrum Pharmaceuticals, Inc. "This ANDA acceptance is a significant milestone in our ongoing effort to build Spectrum Pharmaceuticals' generic drug business. While we await the FDA's action on our application for ciprofloxacin, we are working on our distribution and marketing arrangements, as well as at least two more additional ANDA filings planned for this year."
Last year, Spectrum and JBCPL formed NeoJB LLC to enable Spectrum to benefit from JBCPL's high quality, lower cost drug manufacturing capabilities through the sale of JBCPL's generic drugs in the United States. JBCPL will benefit from Spectrum's skills in managing the regulatory and marketing functions in the United States. NeoJB LLC is an 80% and 20% joint venture of Spectrum and a subsidiary of J.B. Chemicals & Pharmaceuticals Ltd. respectively.