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The U.S. Food and Drug Administration was unable to inspect the company’s South Korea-based manufacturing plant, a step required before the approval of the drug, the company said, sending its shares down 2.3% before the bell.
“We are actively working with the FDA to find a way to expedite the plant inspection,” Chief Executive Officer Joe Turgeon said in a statement.
The company clarified that the move was not a Complete Response Letter (CRL) from the FDA. Receiving a CRL indicates the regulator has completed its review of a new drug application and decided not to approve it in its present form.
Spectrum is seeking approval for its drug Rolontis to treat Neutropenia, a side effect of the treatment of cancer with chemotherapy or radiation therapy.
