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NDA submission for AP-48, Alza's follow-on product for Duragesic (fentanyl transdermal system), is delayed indefinitely due to a need for additional data, the company says Dec. 8. Alza originally planned to file by early 2004. Mylan intends to launch generic Duragesic by July, prior to expiration of Alza's pediatric exclusivity period (1"The Pink Sheet" Dec. 8, 2003, p. 26)...
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