Search Results for 'REMS'

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Product: Samsca®(tolvaptan) Tablets (Jynarque)
Company: Otuska
Petition Filer: Otuska
Petition Number(s): 2019P-4002
Date of Petition: August 26, 2019
Responding Petitions:

Issue and Implication: Whether FDA must apply the same REMS restrictions to a product with the same active ingredient but is not the same as the REMS product.

Action Requested by Petitioner: The Petitioner is asking FDA to remove the Reference List Drug designation to the 60mg strength of Samsca®(tolvaptan) Tablets and refuse to approve an ANDA’s for this product.

Summary of Petition(s): Back in 2009, FDA approved Samsca®(tolvaptan) Tablets 60mg (NDA 022275). However, Otuska never marketed this product. It had been approved for significant hypervolemic and euvolemic hyponatremia. In 2016, a petition was filed to determine whether the product had been discontinued for reasons of safety or efficacy. FDA closed this petition (2016P-0974), noting that the product had not been discontinued for reasons of safety or efficacy and that ANDA’s would be accepted for filing.

In 2018, FDA then approved another tolvaptan 60mg product which Otsuka branded as Jynarque®(tolvaptan). This product had additional indications essentially for the reduction of kidney failure and particularly for adults at risk for rapidly progressing autosomal dominant polycystic kidney disease (ADPKD), and due to the nature of the disease, included a REMS program for it. Particularly, the REMS program considered careful dose titration and mixed dosing such as 45mg in the morning, then 15mg taken 8 hours later. Then, the REMS called for additional dosing at intervals to increase the medication, if tolerated.

The REMS program was incorporated in the un-marketed Samsca 60mg product which label added a boxed warning specifically stating that it should not be used for ADPKD without the REMS program in place. Without the REMS dosing in place, patients are at risk for drug-induced liver injury.

From this, Petitioner argues that the ANDA’s for the Samsca tolvaptan product should not be approved. Moreover, it also states that the FDA should reconsider its determination about the safety of the product in the prior petition and state that it was discontinued for reasons of safety. In short, there is a serious risk that the generic tolvaptan will be prescribed without any REMS program in place and thus place patients at risk.

FDA Action: Pending.

Citizen Petition

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