Spectrum Pharmaceuticals Inc has received approval from the Office of Generic Drugs of the US Food and Drug Administration (FDA) for the Abbreviated New Drug Application (ANDA) for ciprofloxacin tablets in 250 mg, 500 mg and 750 mg strengths. Spectrum's ciprofloxacin is the generic version of Bayer Corporation's Cipro tablets, a broad-spectrum antibiotic indicated for the treatment of several types of infection.
"The approval of the ANDA for ciprofloxacin, our first-ever ANDA filed with the FDA, is a watershed event for the company and provides an important validation of our strategy and capabilities," stated Rajesh C Shrotriya, chairman, CEO and president of Spectrum Pharmaceuticals, Inc.
He added, "We now have a foundation from which to grow our generic drug business and to achieve our objective of having 15-20 generic drugs FDA approved and marketed in the US within the next five years. With two ANDAs -for fluconazole tablets and carboplatin injection -currently under active review at the FDA, at least three additional ANDAs expected to be filed in the next four months, and an additional 10 or more ANDAs expected to be filed over the next 2-3 years, we believe we can achieve this goal."
The ANDA for ciprofloxacin was filed with the FDA by NeoJB, LLC, a joint venture between Spectrum and J.B. Life Science Overseas Ltd, a subsidiary of JB Chemicals & Pharmaceuticals (JBCPL), and was accepted by the FDA in May 2003. In January 2004, JBCPL received FDA approval to manufacture tablet dosage forms of drug products, including ciprofloxacin, at one of its pharmaceutical manufacturing facilities in India. In August 2003, Spectrum entered into an alliance with Lannett Company for the distribution and marketing of ciprofloxacin in the United States, the company release says.
The ciprofloxacin ANDA approval triggers a $750,000 equity investment from an entity affiliated with JBPCL. Spectrum received a $250,000 equity investment from the same investor in 2003 following acceptance by the FDA of the ANDA.
Two ANDAs for fluconazole and carboplatin are under active review by the FDA. The ANDA for fluconazole was filed by NeoJB, LLC based on manufacturing data generated at the now FDA approved JBCPL manufacturing facility and the same bio-equivalency study site as that for ciprofloxacin, the release added.