Search Results for 'REMS'

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Product: Duragesic®(fentanyl) Transdermal System
Company: Janssen
Petition Filer: Mylan
Petition Number(s): 2006P-0123 (renumbered 2006P-0329)
Date of Petition: March 17, 2006
Responding Petitions: PriCara (Ortho-McNeil)
Special Note: This product has been subject to numerous petitions (see Archives – Product Petitions.)

Issue and Implication: Whether any manufacturer of a fentanyl patch needs to conduct studies using an overlay adhesive to ensure safe use of the product.

Action Requested by Petitioner: Mylan is requesting that all current and future manufacturers of a fentanyl patch be required to conduct additional tests with an overlay adhesive as part of their approvals and continued use.

Summary of Petition(s): Mylan is a generic version of Duragesic. Apparently, several fentanyl patches in the market are having a difficult time adhering to the skin, and FDA has sent an Alert in July 2005 regarding this. Because of this, some physicians and patients are using their own adhesive overlays to make sure the patches stick properly. Mylan is currently conducting a study to ensure that its patch is not adversely affected by such an overlay and is requesting FDA to do the same. What is not too clear from this Petition is whether other generics are having sticking problems or even Janssen as it suggested it may be trying a new matrix patch in Europe. Mylan issued a supplement on March 23, 2006 adding some reference sources.

On May 30, 2006, Mylan also submitted an amendment to its petition. In this supplement, it included results of its study showing that the use of a Bioclusive™ overlay has no effect on rate of absorption. It also reiterates that the standards sought in the Petition should apply to both ANDA applicants and holders.

On July 20, 2006, PriCara, a unit of Ortho-McNeil submitted a response supporting the Mylan petition. Mylan submitted an additional supplement on August 10, 2006 which simply reiterated prior points. Mylan also made an additional filings on 11/14/2006 and 7/25/2007.

FDA Action: Pending. On September 14, 2006, FDA issued an Interim Response. On September 20, 2007, FDA notified Mylan that it was placing the meeting minutes of a March, 2007 meeting between FDA and Mylan in the file and that the meeting was not a “private meeting.” On November 4, 2010, FDA granted-in-part, denied-in-part this petition.

Citizen Petition
Supplement to Petition (March 23, 2006)
Supplement to Petition (May 30, 2006)
PriCara Response
Mylan Supplement (August 10, 2006)
FDA Interim Response
FDA Notice of Minutes
Meeting Minutes
Mylan Supplemement (July 25, 2007)
FDA Action

Product: Duragesic®(fentanyl) TTS
Company: Janssen
Petition Filer: Mylan Labs
Petition Number(s): 2006P-0290 (renumbered 2006P-0016)
Date of Petition: July 24, 2006
Responding Petitions:

Issue and Implication: Whether Duragesic and the generic fentanyl patch should include a risk management program.

Action Requested by Petitioner: “The Petitioner requests the Agency determine the necessity for a Risk Management Program for transdermally administered fentanyl drug products. If the Agency determines a Risk Management Program is necessary, the petitioner requests the Agency to develop and adopt a single, unified Risk Management Program for all transdermal fentanyl drug products based on input provided by all sponsors of approved marketing applications for transdermal fentanyl products.” (p1)

Summary of Petition(s): As is well known, fentanyl is an opioid that is addictive and can be abused. Mylan is requesting that there be a unified risk management program that all manufacturers would need to follow. The plan includes a great deal of communication to providers, distributors, and patients.

FDA Action: On March 5, 2013, FDA issued its response granting/denying this petition. In short, since the petition was filed, FDA was given the authority to create REMS programs and did so for opioid products. The existing programs cover this product, and the petition is granted, in a sense, as the requests are satisfied. However, FDA did deny some specific points raised in the petition.

Citizen Petition
FDA Action

Product: Duragesic®(fentanyl) Patch
Company: Johnson & Johnson
Petition Filer: Mylan
Petition Number(s): 2009P-0415
Date of Petition: September 29, 2009
Responding Petitions:

Issue and Implication: Whether the newly announced Matrix patch for Duragesic poses a risk of safety and abuse.

Action Requested by Petitioner: The petitioner is requesting that FDA stay any approval of the newly designed Duragesic.

Summary of Petition(s): Petitioner states that J&J announced that is is completing its 505(b)(2) application for a newly designed Duragesic patch. Using a matrix technology (rather than gel-filled resevoir patch), it claims that the new patch will be better. Petitioner claims that the new patch will deliver a higher load concentration of drug through the skin than what is currently on the market. As such, it poses an unnecessary health risk to patients already on the patch and possibly opens up the likelihood for abuse.

FDA Action: On February 26, 2010, FDA denied this petition.

Citizen Petition
FDA Action

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