Search Results for 'REMS'

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Product: Suboxone®(buprenorphine and naloxone) Sublingual Film
Company: Reckitt Benckiser
Petition Filer: Hyman Phelps, a law firm
Petition Number(s): 2011P-0869
Date of Petition: December 20, 2011
Responding Petitions: BioDelivery Sciences International

Issue and Implication: Whether a 505(b)(2) NDA applicant must reference this product and whether purity standards established in a prior petition for a different formulation must be applied to this product.

Action Requested by Petitioner: The Petitioner is requesting that FDA refuse to accept any 505(b)(2) NDA application for a polymer film application of this product to the mucosal membranes without referencing Suboxone (NDA #22-410) and to deny any application unless it meets the purity profile established in a similar petition (2009P-0325 – see Product Petition Archives).

Summary of Petition(s): Petitioner notes that there are two formulations that are relevant to this petition: the sublingual tablet and sublingual film. Petitioner claims that another company is conducting trials for a sublingual film product. Based on this, Petitioner is requesting that the 505(b)(2) NDA applicant must reference the sublingual film product (NDA #22-410) and makes a basic regulatory argument in support. In short, it claims that the product must match the RLD product formulation in order for better comparison and also to ensure that the associated market exclusivities and patents are honored and which may restrict the approval time for the 505(b)(2) NDA. In addition, Petitioner also states that the 505(b)(2) NDA must adhere to purity standards which the FDA established in another petition (2009P-0325).

On May 25, 2012, BioDelivery Sciences International (BDSI) submitted a response requesting FDA to deny the request. First, BDSI noted that 21 CFR 314 delineate a few criteria for FDA to refuse to accept a 505(b)(2) application, and none of these apply here. Second, a 505(b)(2) applicant may legally file an application on any approved product. In this case there are two approved products to choose from, and the FDA cannot require that one of the two be the RLD.

On June 26, 2013, Petitioner submitted a reply to the BDSI comment. Petitioner reiterates its position and states that FDA has the authority to grant the petition.

FDA Action: On September 20, 2013, FDA denied this petition in substance, allowing 505(b)(2) applications that do not reference this product. While it “granted” the Petitioner’s viewpoint that impurities should be limited to appropriate amounts, it denied the request for certain levels.

Citizen Petition
BioDelivery Sciences Response
Petitioner’s Reply
FDA Action

Product: Suboxone®(buprenorphine and naloxone) and Subutex®(bupernophine)
Company: Reckitt Benckiser
Petition Filer: Reckitt Benckiser
Petition Number(s): 2012P-1028
Date of Petition: October 1, 2012
Responding Petitions: Amneal, American Society of Addiction Medicine, Rocky Mountain Poison and Drug Center, Actavis, Buprenorphine Products Manufacturer’s Group

Issue and Implication: Whether an ANDA product must have a similar REMS program in order to be AB rated to the Reference List Drug.

Action Requested by Petitioner: The Petitioner would like FDA to deny any ANDA applicant using Suboxone or Subutex as its reference list drug unless it uses the same risk mitigation program (RiskMAP).

Summary of Petition(s): These products contain buprenorphine which is an opioid. Of course, it has been well documented and known regarding the risk of opioid addiction and abuse. Over the past decade, these products were targeted by drug users and abused. However, working with FDA, Petitioner evolved several risk mitigation strategies including patient monitoring and education. Studies have shown that the RiskMAP strategy was effective in reducing abuse and adverse events in children. As such, Petitioner argues that to maintain the same safety profile as the RLD product, any ANDA filer should have to institute the same RiskMAP strategy – anything short of that would be to allow unsafe products on the market.

On October 23, 2012, Amneal and the American Society of Addiction Medicine (ASAM) submitted a response. The ASAM response was not published by FDA. However, the Amneal response asked FDA to deny this petition. Amneal states that FDA does not have the authority to grant the requests in the petition. Moreover, the petition fails to establish a legitimate issue regarding safety and is merely filed to delay ANDA approval.

On November 20, 2012, Reckitt Benckiser replied to Amneal’s response. The Petitioner simply commented that the Amneal response was filled with many misstatements and mischaracterizations of fact and lacked understanding of the safety issues and REMS regulations. On December 11, 2012, Reckitt Benckiser submitted a memo as an errata of the reply to Amneal.

On December 11, 2012, Actavis submitted a response. Actavis supports that comments from Amneal and asks FDA to deny the petition. Actavis provides additional detail to the argument and makes the point that FDA has no authority to approve the petition as requested. In effect, the petition is asking FDA to create new rules and requirements for ANDA’s to be approved. Only strained readings of statutes and regulations could provide a glimmer of hope to advance these arguments. However, basic review of these rules and the thought about long-term ramifications would lead anyone to reject the petition and it would create additional and unnecessary and illegal obstacles to ANDA approval.

On December 13, 2012, the Rocky Mountain Poison and Drug Center submitted a confidential study on the effect of buprenorphine exposure to children.

On December 31, 2012, the Buprenorphine Products Manufacturer’s Group (BPMG) submitted a response requested that FDA deny the petition. BPMG claims that the petition is intended solely for delay purposes which grounds alone are sufficient to reject the petition. However, the petition also fails to submit enough data or evidence to justify the actions requested.

FDA Action: On February 22, 2013, FDA denied this petition.

Citizen Petition
Amneal Response
Beckitt Benckiser Reply
Beckitt Benckiser Reply (errata sheet)
Actavis Response
Buprenorphine Products Manufacturer’s Group Response
FDA Action
Amneal Response
American Society of Addition Medicine Response
Amneal Response 2
Buprenorphine Products Manufacturer’s Group Response 2

Product: Suboxone®(buprenorphine and naloxone) Sublingual Film
Company: Reckitt Benckiser
Petition Filer: Hyman Phelps, a law firm
Petition Number(s): 2013P-0995
Date of Petition: September 5, 2013
Responding Petitions:

Issue and Implication: Whether a 505(b)(2) NDA applicant must reference this product and whether purity standards established in a prior petition for a different formulation must be applied to this product.

Action Requested by Petitioner: From the outset of this petition, the Petitioner notes that it is requesting the same action as the above petition (2011P-0869) which is actually attached to this petition. The precipitating event for this petition is that on August 1, 2013, BioDelivery Sciences International announced that it had submitted an 505(b)(2) NDA for a similar product called Bunavail without referencing Suboxone.

FDA Action: On September 20, 2013, FDA denied this petition in substance, allowing 505(b)(2) applications that do not reference this product. While it “granted” the Petitioner’s viewpoint that impurities should be limited to appropriate amounts, it denied the request for certain levels.

Citizen Petition
FDA Action

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