Search Results for 'REMS'

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Product: Xyrem®(sodium oxybate) Oral Solution
Company: Jazz Pharmaceuticals
Petition Filer: Jazz Pharmaceuticals
Petition Number(s): 2012P-0499
Date of Petition: May 28, 2012
Responding Petitions: Roxane

Issue and Implication: Whether FDA must post bioequivalence standards for each produc in the Orange Book. Whether current bioequivalence standards are sufficient to ensure safe use of this product.

Action Requested by Petitioner: The Petitioner is requesting that FDA post the required studies ANDA applicants need to submit an application for this product. Petitioner is also requesting that FDA not accept any ANDA’s until this has been done. Petitioner also requests that FDA require ANDA applicants to conduct in vivo studies.

Summary of Petition(s): Petitioner manufactures Xyrem which is a controlled substance and has a Risk Evaluation and Mitigation Strategy (REMS) in place as it can be subject to abuse. With that, Petitioner makes a literal, technical argument. It argues that FDA is required to post in the Orange Book each product’s bioequivalence requirements. In other words, FDA is required to post whether the product needs an in vitro BE study, in vivo study, or both in order for an ANDA to file its application and make an AB rated product. Petitioner claims that FDA must do this before accepting any ANDA. Petitioner argues that FDA has failed to do so for Xyrem and has improperly accepted three ANDA’s for this product. So, it first asks FDA to post the required studies.

Moreover, because of its technical nature and its characteristics of being a controlled substance, subject to REMS, Petitioner requests that FDA post that an ANDA applicant must conduct in vitro bioequivalence studies and also in vivo studies establishing that the product is equivalent in terms of manufacturing, pH, incipients, impurities, degradants and contaminants. It argues for these studies on an additional ground regarding absorption where other products may not have the same rate of absorption as Xyrem if not tested by in vivo study.

On July 23, 2012, Petitioner submitted an supplement. The supplement is technical in nature, noting that the FDA acceptance letter only noted 2 of the 3 actions requested and thus Petitioner wants to make sure that all three requests are considered.

On November 2, 2012, Roxane submitted a response, asking FDA to reject the petition. In short, Roxane argues that there is no scientific or legal basis to grant the petition. First, FDA has already rejected the argument that it cannot accept any ANDA’s for approval without first publishing bioequivalence standards. In addition, the District Court for the District of Columbia has already rejected this argument. Second, there is no scientific basis to support the petitioner’s arguments for different bioequivalence tests and standards.

FDA Action: On November 13, 2012, FDA denied this petition.

Citizen Petition
Supplement
Roxane Response
FDA Action

Product: Xyrem®(sodium oxybate) Oral Solution
Company: Jazz Pharmaceuticals
Petition Filer: Jazz Pharmaceuticals
Petition Number(s): 2012P-0733
Date of Petition: July 16, 2012
Responding Petitions: Roxane

Issue and Implication: Whether an ANDA application must duplicate a Risk Evaluation Management Strategy (REMS) program if the reference list drug has a REMS program and whether a submission of a REMS program by an ANDA applicant constitutes another filing.

Action Requested by Petitioner: The Petitioner would like the FDA to deny any ANDA applicant (and it is aware that Roxane has filed an ANDA and applies same request to Roxane) that does not have an adequate REMS program included in its ANDA. Furthermore, if an ANDA filer does not have a REMS program at the time of filing the ANDA, and then it adds it to the ANDA, Petitioner requests that this action constitute a separate ANDA filing, requiring a PIV notice and second 30 month stay.

Summary of Petition(s): Petitioner notes that its narcolepsy product has a REMS program. Stemming from adverse events and the use of similar products in “date-rape” cases, FDA has restricted the use and distribution channels for the product including warnings and other communications about the product. Jazz is aware that Roxane has filed an ANDA and makes the argument that the REMS regulations would require Roxane or any ANDA filer to have a like REMS program. In addition, under its interpretation of the law, it also argues that the addition of a REMS program to a pending ANDA would trigger a second PIV notice letter with subsequent patent case creating another 30 month stay.

On December 7, 2012, Roxane submitted a response asking FDA to deny the petition. Roxane notes that it had filed its ANDA application over two years ago, and FDA accepted the application for review. It further notes that Jazz has already filed a petition (see above) trying to create another obstacle to approval which petition FDA has denied. In this petition, Jazz makes two arguments that have no legal or regulatory merit – an ANDA applicant does not need to submit an exhaustive REMS plan when filing the ANDA and these are details that are usually worked out with FDA during the review and approval process. The law and regulatory application and practice supports that Roxane submitted an appropriate ANDA and cannot be required to re-file with a complete REMS package included. Also, there is no basis for another 30 month stay. The petition has been filed merely to thwart generic competition, and FDA should deny it.

FDA Action: On December 14, 2012, FDA denied this petition.

Citizen Petition
Roxane Response
FDA Action

Product: Xyrem®(sodium oxybate) Oral Solution
Company: Jazz Pharmaceuticals
Petition Filer: Jazz Pharmaceuticals
Petition Number(s): 2016P-2672
Date of Petition: September 9, 2016
Responding Petitions: Par Pharmaceutical

Issue and Implication: Whether an ANDA label can carve out certain drug-drug interactions from its label and still have an adequate label.

Action Requested by Petitioner: The Petitioner is requesting that FDA refuse to approve of any ANDA application which label does not include the drug-drug information regarding divalproex.

Summary of Petition(s): Similar to the petition above, Petitioner makes claims that its label contains a REMS strategy to ensure safe and effective use. It also states that critical label information includes its interactions with divalproex and that without this information in the label, the drug cannot be safely used and administered. Petitioner states that at least one ANDA filer is attempting to carve out the statements regarding divalproex from its label via a Section viii statement, and Petitioner argues that its label is no longer a label without these data.

On November 17, 2016, Par submitted a reply. Par asked the FDA to deny the petition on one simple ground. It notes that Jazz marketed its product for years without the labeling information it now argues is critical for its safe and effective use. The REMS and label language had been amended to its current state, and the petition is really a blatant attempt to prevent generic competition.

On January 13, 2017, Jazz submitted a reply, simply refuting several of the Par assertions and reiterating its position.

FDA Action: On January 17, 2017, FDA granted this petition

Citizen Petition
Par Comment
Jazz Reply
FDA Action

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