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Generic Version of Paraplatin Gains FDA Approval

IRVINE, Calif., June 14 /PRNewswire-FirstCall/ -- Spectrum Pharmaceuticals, Inc. (Nasdaq: SPPI - News) announced today that it 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 carboplatin injection in 50 mg, 150 mg and 450 mg multi-dose vials. Carboplatin is a platinum-based, anti-cancer drug used in the treatment of patients with a wide variety of tumor types. The branded product, Paraplatin®, is marketed by Bristol-Myers Squibb.

"This approval of carboplatin marks our entry into the generic injectable market, most notably the anti-cancer segment, an area where we are focusing significant new product development efforts," stated Rajesh C. Shrotriya, M.D., Chairman, Chief Executive Officer and President of Spectrum Pharmaceuticals, Inc. "We believe that our generic oncology products will be synergistic with our proprietary development program and enable us to promote the brand awareness of Spectrum Pharmaceuticals ahead of the entry of our proprietary oncology products. The approval of now our second ANDA is another component to our stated objective of having 15-20 generic drugs, including several additional generic oncology drugs, FDA approved and marketed in the U.S. within the next five years."

In April, Spectrum entered into an alliance with Cura Pharmaceuticals Co., Inc. for the marketing and distribution of carboplatin injection in the United States. With extensive experience in the generic marketplace, and the generic oncology market in particular, Cura is expected to be launching Spectrum's product in the next several days.

Source: Spectrum Pharmaceuticals, Inc.

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