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Spectrum Pharmaceuticals
SPPI announced today that it has
received a Complete Response Letter from the U.S. Food and Drug
Administration (FDA). A Complete Response Letter is a communication from
the FDA that informs companies that an application cannot be approved in
its present form. In the letter, the FDA did not identify any clinical
deficiency in Spectrum's NDA package.
"We will work swiftly with the FDA to address the Complete Response
Letter," said Rajesh C. Shrotriya, MD, Chairman and Chief Executive
Officer of Spectrum Pharmaceuticals. "We remain committed to bringing
EVOMELA to the market for
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