Search Results for 'REMS'

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Product: Kuvan™(sapropterin) Tablets
Company: Biomarin
Petition Filer: K&L Gates, a law firm
Petition Number(s): 2013P-0846
Date of Petition: July 23, 2013
Responding Petitions: Greenberg Traurig

Issue and Implication: Whether an ANDA can establish bioequivalence with a reference list drug sourced outside the US.

Action Requested by Petitioner: The Petitioner is asking FDA to permit an ANDA filer to establish bioequivalence with the reference list drug sourced from Israel.

Summary of Petition(s): Approved in 2007, Kuvan is a product that has a severely limited distribution process. Though it does not have a formal REMS program, FDA required a patient registry for this product. Biomarin has a restrictive system of distributing this product to its patients and does not sell the product through traditional wholesalers. Petitioner represents a potential ANDA filer which has been unable to source enough reference list drug, in spite of its direct requests to Biomarin, to set up bioequivalence testing and study. However, it has been able to source the product in Israel which appears to be substantially the same as the US product. Petitioner argues that FDA should allow such a BE test and ANDA to move forward and be permitted. It notes that nothing in the statute or regulations require a US sourced reference drug. Additionally, as a policy matter, FDA should allow the ANDA as preventing it would encourage abuse of the Hatch Waxman system and discourage future ANDA’s by allowing brands to restrict distribution.

FDA Action: On November 18, 2014, FDA denied this petition. After FDA denied this petition, it posted a response from Greenberg Traurig on November 25, 2014 which is dated December 2013.

Citizen Petition
FDA Action
Greenberg Traurig

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