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DJ Spectrum Pharma Gets FDA OK For Generic Anthrax Drug>SPPI


IRVINE, Calif. (Dow Jones)--Spectrum Pharmaceuticals Inc. (SPPI) received federal approval to market its generic version of antibiotic ciprofloxacin, which was used to prevent infection among people exposed or potentially exposed to anthrax.

Spectrum, a biopharmaceutical company that specializes in developing cancer drugs, said the Food and Drug Administration cleared the way to sell the tablets, the generic version of Bayer AG's (BAY) Cipro, in 250-milligram, 400-milligram and 750-milligram strengths.

The Abbreviated New Drug Application, or ANDA, for ciprofloxacin tablets was filed by NeoJB LLC, a joint venture between Spectrum and Indian drug company J.B. Chemicals & Pharmacueticals Ltd., filed the Abbreviated New Drug Application, in May 2003.

The FDA approval triggers a $750,000 equity investment from an entity affiliated with J.B. Chemicals. Back in 2003, Spectrum received a $250,000 equity investment from the same investor following the acceptance of the application by the FDA.

In 2003, Spectrum posted a loss of $10.4 million on revenue of $1 million.


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09-10-04 1703ET