Spectrum Pharmaceuticals, Inc. has filed its eighth ANDA (Abbreviated New Drug Application), third for an ophthalmic (eye care) product, with the US FDA on behalf of FDC Ltd.
Under the terms of the agreement, FDC will develop and manufacture the product, and Spectrum will be responsible for all regulatory, marketing and distribution matters in the United States.
"We continue to achieve our corporate objectives in a timely manner," stated Rajesh C. Shrotriya, chairman, CEO and president of Spectrum Pharmaceuticals, Inc. "Our goal is to continue to aggressively pursue additional ANDA filings in 2005, including ANDAs for additional injectable products, and to have 15-20 generic drugs FDA approved and marketed in the US before 2009," he added.
Spectrum Pharmaceuticals currently has seven ANDAs that are pending at the FDA, including an ANDA with Paragraph IV certification for sumatriptan succinate injection. The Company's ANDA for ciprofloxacin received FDA approval in September 2004. Sales of ciprofloxacin began in late fourth quarter 2004 through Lannett Co., Spectrum's marketing and distribution partner for ciprofloxacin in the United States.