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Article: U.S. Food and Drug Administration Issues Complete Response Letter Regarding PEGINTRON[R] for Malignant Melanoma.

Article from:
Hepatitis Weekly
Article date:
November 16, 2009
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Schering-Plough Corp. (NYSE:SGP) announced the U.S. Food and Drug Administration (FDA) has issued a complete response letter to the company's supplemental Biologics License Application regarding PEGINTRON=AE (pegylated interferon alfa-2b) for the adjuvant treatment of patients with stage III malignant melanoma after complete lymphadenectomy (see also Melanoma).

Schering-Plough will work closely with FDA to respond to outstanding concerns related to the PEGINTRON melanoma filing.

In early October, the FDA's Oncologic Drugs Advisory Committee recommended approval of PEGINTRON in this indication by a vote of 6 to 4. Schering-Plough had sought approval for ...

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