FDA Letter Denying Citizen Petitions
On January 28, 2005, the FDA denied pending citizen petitions intended to prevent or delay the approval of generic versions of Johnson & Johnson’s Duragesic^® product (fentanyl transdermal system). FDA denied the petitions of ALZA Corporation; Drs. Brookoff and Voth; London & Mead; and Dr. Steven L. Shafer.

To access the FDA's letter denying the petitions in PDF format, CLICK HERE.

Supporting Statement
On January 27, 2005, counsel for Noven submitted a supporting statement by Donald R. Jasinski, M.D. to the FDA in response to pending citizen petitions intended to prevent or delay the approval of certain generic versions of Johnson & Johnson’s Duragesic^® product (fentanyl transdermal system).

To access the supporting statement by Dr. Jasinski in PDF format, CLICK HERE.

Brookoff Addendum Response
On January 19, 2005, Noven submitted supplemental comments to the FDA in response to a December 30, 2004 citizen petition addendum filed by Drs. Brookoff and Voth intended to prevent or delay the approval of certain generic versions of Johnson & Johnson’s Duragesic^® product (fentanyl transdermal system).

To access Noven's supplemental comments to this petition addendum in PDF format, CLICK HERE.

London & Mead Petition Response
On December 30, 2004, Noven submitted comments to the FDA in response to a pending citizen petition filed by the law firm of London & Mead (the "London & Mead Petition") intended to prevent or delay the approval of certain generic versions of Johnson & Johnson’s Duragesic^® product (fentanyl transdermal system).

To access Noven's response to the London & Mead Petition in PDF format, CLICK HERE.

CLICK HERE to access the London & Mead Petition as it appears on the FDA website.

Alza Petition Response
On December 23, 2004, Noven submitted comments to the FDA in response to a pending citizen petition filed by Alza Corporation (the "Alza Petition") intended to prevent or delay the approval of certain generic versions of Johnson & Johnson’s Duragesic^® product (fentanyl transdermal system).

To access Noven's response to the Alza Petition in PDF format, CLICK HERE.

CLICK HERE to access the Alza Petition as it appears on the FDA website.

Brookoff Petition Response
On December 10, 2004, Noven submitted comments to the FDA in response to a pending citizen petition filed by Drs. Brookoff and Voth in October 2004 (the "Brookoff Petition") intended to prevent or delay the approval of certain generic versions of Johnson & Johnson’s Duragesic^® product (fentanyl transdermal system).

To access Noven's response to the Brookoff Petition in PDF format, CLICK HERE.

CLICK HERE to access the Brookoff Petition as it appears on the FDA website.