Spectrum Pharmaceuticals Inc has filed an ANDA (Abbreviated New Drug Application) for an ophthalmic product with the US FDA through the electronic submission process.
This is the Company's first ANDA filing on behalf of FDC Ltd and the second electronic submission (the first being that for the ANDA for carboplatin injection). 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, the company said in a release.
"By filing this ANDA, we have achieved yet another one of our stated goals for 2004," stated Rajesh C Shrotriya, chairman, CEO and president of Spectrum Pharmaceuticals, Inc. "We continue to make excellent progress in implementing our strategy and expanding our drug portfolio, as evidenced by the recent approval of the ANDA for ciprofloxacin and the filing of this ophthalmic ANDA. We continue to expect to file at least two additional ANDAs before the end of the year. 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 there is relatively limited competition," he added.
Spectrum Pharmaceuticals currently has two ANDAs for fluconazole and carboplatin that are under active review by the FDA.