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19 Apr 2011

FDA Approves Merck's Sylatron for Injection

The U.S. FDA has approved Merck's SYLATRON for injection, for subcutaneous use.

The U.S. FDA has approved Merck's SYLATRON? (peginterferon alfa-2b) for injection, for subcutaneous use. SYLATRON is indicated for the adjuvant treatment of melanoma with microscopic or gross nodal involvement within 84 days of definitive surgical resection including complete lymphadenectomy. SYLATRON is contraindicated in patients with a history of anaphylaxis to peginterferon alfa-2b or interferon alfa-2b, in patients with autoimmune hepatitis, and in patients with hepatic decompensation (Child-Pugh score >6 [class B and C]).


"Merck is pleased to offer patients with node-positive melanoma this new option to treat the disease,” said Eric Rubin, M.D., vice president of clinical oncology at Merck. “This is the first such therapy approved for the adjuvant trea

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