Spectrum Pharmaceuticals Inc. has filed its second ANDA (Abbreviated New Drug Application) for an ophthalmic (eye care) product with the US FDA on behalf of FDC Ltd. Under the terms of the December 2003 agreement, FDC will develop and manufacture the product, and Spectrum will be responsible for all regulatory, marketing and distribution matters in the United States.
"By filing the second ANDA for an ophthalmic product, we have achieved one of our objectives for 2004," stated Rajesh C. Shrotriya, chairman, CEO and president of Spectrum Pharmaceuticals Inc. "Our five-year goal is to have 15-20 generic drugs FDA approved and marketed in the US based on several differentiated platforms for generic products, including tablets, injectable and ophthalmic/otic products. Our focus is on specialty markets, such as ophthalmics and injectables, including oncology drugs, where competition is less intense," he added.
Spectrum Pharmaceuticals currently has three ANDAs for fluconazole, carboplatin and an ophthalmic product that are pending at the FDA. The Company's ANDA for ciprofloxacin received FDA approval in September 2004. Sales of ciprofloxacin are expected to begin this quarter through Lannett Co, Spectrum's marketing and distribution partner for ciprofloxacin in the United States.
Spectrum Pharmaceuticals is an oncology-focused pharmaceutical company engaged in the business of acquiring, developing and commercializing proprietary drug products which have a primary focus on the treatment of cancer and related disorders, as well as generic drug products for various indications.