Sandoz To Market “Authorized” Generic Of J&J Duragesic
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA is reviewing the merits of citizen petitions regarding approval of generic fentanyl transermal patches, Johnson & Johnson Worldwide Chairman Poon says. The company recommends that investors model greater impact from Duragesic and Concerta generics beyond the first quarter.
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Duragesic, Generics May Warrant Risk Management Plans, FDA Says
The agency will continue to monitor incidents of abuse or misuse of fentanyl transdermal systems and "may consider" requesting brand and generic manufacturers to implement a voluntary risk management plan, FDA says in denying citizen petition requests to delay approval of Duragesic generics.
Duragesic, Generics May Warrant Risk Management Plans, FDA Says
The agency will continue to monitor incidents of abuse or misuse of fentanyl transdermal systems and "may consider" requesting brand and generic manufacturers to implement a voluntary risk management plan, FDA says in denying citizen petition requests to delay approval of Duragesic generics.
Mylan Launches First Duragesic Generic
ANDA approval comes five days after J&J's pediatric exclusivity on the fentanyl patch expired. Mylan's product will face competition from Sandoz' "authorized" generic.