Spectrum Pharmaceuticals, Inc. announced the filing of an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) for fluconazole tablets. NeoJB, LLC, a joint venture between Spectrum Pharmaceuticals and JB Life Science Overseas Ltd a subsidiary of JB Chemicals & Pharmaceuticals, Limited (JBCPL) made the filing.
Under the terms of the agreement, JBCPL will manufacture fluconazole tablets and NeoJB will oversee marketing and distribution of the drug in the United States. If approved by the FDA, Spectrum expects to generate revenue from sales of fluconazole in 2005.
Fluconazole is currently marketed by Pfizer under the brand name Diflucan and is used to treat various fungal infections. According to industry sources, annual sales of Diflucan tablets in the US are estimated to be in excess of $500 million.
"We continue to make rapid progress in implementing our generic strategy," stated Rajesh C Shrotriya, MD, chairman, CEO and president of Spectrum Pharmaceuticals, Inc. "By filing the ANDA for fluconazole, our third ANDA this year, we met yet another important milestone that we set for 2003. With the recent addition of two industry veterans, with a combined experience of participating in filing over 125 ANDAs and launch of multiple generic drugs at leading drug companies, and our partner's experience as a leader in launch of multiple Generic Drugs in India and other countries, we believe we are well positioned to continue to broaden our generic drug portfolio. To this end, we expect to file in 2004 several additional ANDAs, including at least two for ophthalmic products, through our relationships in India. We plan to use any revenue realized from our generic business to continue to advance our existing late-stage oncology product candidates as well as to expand our pipeline through the acquisition of additional late- stage compounds."
Spectrum Pharmaceuticals, filed two ANDAs earlier this year for ciprofloxacin and carboplatin injection that, if approved, could generate revenue in 2004 and 2005, respectively.