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news.Prescription drug firm Spectrum Pharmaceuticals has filed its ninth abbreviated new drug application, the fourth for an eye care product, with the FDA on behalf of FDC Ltd of India.
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Under the terms of the agreement, FDC will develop and manufacture the ophthalmic product and Spectrum Pharmaceuticals will be responsible for all regulatory, marketing and distribution matters in the US.
“We continue to achieve our corporate objectives in a timely manner,” stated Dr Rajesh Shrotriya, chairman, CEO and president of Spectrum Pharmaceuticals. “Our goal is to continue to aggressively pursue additional abbreviated new drug application (ANDA) filings in 2005, including ANDAs for additional injectable products, and to have 15 to 20 generic drugs FDA approved and marketed in the US before 2009.”
Spectrum Pharmaceuticals currently has eight ANDAs that are pending at the FDA, including an ANDA with Paragraph IV certification for sumatriptan succinate injection, a generic version of GlaxoSmithKline’s migraine drug Imitrex.
The company’s ANDA for ciprofloxacin received FDA approval in September 2004 and sales began in late 2004 through Lannett Co, Spectrum’s marketing and distribution partner for ciprofloxacin in the US. Ciprofloxacin is a generic version of Bayer Corporation’s Cipro.