Spectrum Pharmaceuticals Announces Filing of Eighth ANDA With the FDA

Spectrum Pharmaceuticals has filed its eighth abbreviated new drug application (ANDA), third for an ophthalmic product, with the FDA on behalf of FDC.

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 U.S. Spectrum currently has seven ANDAs 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, Spectrum's marketing and distribution partner for ciprofloxacin in the U.S.